Trial Outcomes & Findings for Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery (NCT NCT00408408)

NCT ID: NCT00408408

Last Updated: 2017-09-18

Results Overview

Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.

• Recruitment status: UNKNOWN
• Study phase: PHASE3
• Target enrollment: 1206 participants
• Primary outcome timeframe: Time of surgery, on average 6 or 13 months
• Results posted on: 2017-09-18

Participant Flow

Participant milestones

Measure	Arm 1A: Docetaxel Then AC Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Overall Study STARTED	201	199	204	201	197	204
Overall Study COMPLETED	199	196	204	194	192	201
Overall Study NOT COMPLETED	2	3	0	7	5	3

Reasons for withdrawal

Measure	Arm 1A: Docetaxel Then AC Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Overall Study No follow up data	2	3	0	7	5	3

Baseline Characteristics

Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery

Baseline characteristics by cohort

Measure	Docetaxel Then AC n=201 Participants Docetaxel then AC	Docetaxel + Bev Then AC + Bev n=199 Participants Docetaxel + Bev then AC + Bev	Docetaxel + Capecitabine Then AC n=204 Participants Docetaxel + Capecitabine then AC	Docetaxel + Cape + Bev Then AC + Bev n=201 Participants Docetaxel + Cape + Bev then AC + Bev	Docetaxel + Gem Then AC n=197 Participants Docetaxel + Gem then AC	Docetaxel + Gem + Bev Then AC + Bev n=204 Participants Docetaxel + Gem + Bev then AC + Bev	Total n=1206 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 9.1 • n=5 Participants	49 years STANDARD_DEVIATION 9.6 • n=7 Participants	49 years STANDARD_DEVIATION 9.8 • n=5 Participants	49 years STANDARD_DEVIATION 10.4 • n=4 Participants	48 years STANDARD_DEVIATION 9.9 • n=21 Participants	48 years STANDARD_DEVIATION 9.8 • n=10 Participants	48 years STANDARD_DEVIATION 9.7 • n=115 Participants
Sex: Female, Male Female	201 Participants n=5 Participants	199 Participants n=7 Participants	204 Participants n=5 Participants	201 Participants n=4 Participants	197 Participants n=21 Participants	204 Participants n=10 Participants	1206 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: Time of surgery, on average 6 or 13 months

Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.

Outcome measures

Measure	Arm 1A: Docetaxel Then AC n=199 Participants Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev n=196 Participants Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC n=204 Participants Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev n=194 Participants Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC n=192 Participants Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev n=201 Participants Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Pathologic Complete Response (pCR) of the Primary Tumor in the Breast	33.7 percentage of patients Interval 27.1 to 40.2	31.6 percentage of patients Interval 25.1 to 38.1	23.5 percentage of patients Interval 17.7 to 29.4	36.1 percentage of patients Interval 29.3 to 42.8	27.6 percentage of patients Interval 21.3 to 33.9	35.8 percentage of patients Interval 29.2 to 42.4

SECONDARY outcome

Timeframe: Time of surgery, on average 6 or 13 months

Population: Arm 1A there is no follow up data for 3 patients; Arm 1B no follow up date for 6 patients; Arm 2A no follow up data for 1 patient; Arm 2B no follow up data for 11 patients; Arm 3A no follow up data for 9 patients; and Arm 3B no follow up data for 6 patients

Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.

Outcome measures

Measure	Arm 1A: Docetaxel Then AC n=198 Participants Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev n=193 Participants Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC n=203 Participants Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev n=190 Participants Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC n=188 Participants Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev n=198 Participants Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
pCR in the Breast and Nodes	27.3 percentage of patients Interval 21.3 to 33.6	24.4 percentage of patients Interval 18.6 to 30.6	18.7 percentage of patients Interval 13.7 to 24.4	27.4 percentage of patients Interval 21.2 to 33.8	22.9 percentage of patients Interval 17.2 to 29.1	30.3 percentage of patients Interval 24.1 to 36.8

SECONDARY outcome

Timeframe: Assessed at cycle 5 of chemotherapy, on average at 15 weeks

Population: For Arm 1A there is no follow up data for 1 patient; Arm 1B no follow up data for 5 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 7 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 4 patients

Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.

Outcome measures

Measure	Arm 1A: Docetaxel Then AC n=200 Participants Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev n=194 Participants Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC n=198 Participants Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev n=194 Participants Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC n=190 Participants Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev n=200 Participants Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy	77 percentage of patients Interval 70.5 to 82.2	87.6 percentage of patients Interval 82.1 to 91.5	73.7 percentage of patients Interval 67.0 to 79.3	84 percentage of patients Interval 78.1 to 88.5	82.6 percentage of patients Interval 76.5 to 87.3	88 percentage of patients Interval 82.6 to 91.8

SECONDARY outcome

Timeframe: Three to four weeks after the last chemotherapy dose on average 6 or 13 months

Population: For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients

The percentage of patients assessed by physical exam as Clinical Complete Response or Clinical Partial Response according to RECIST.

Outcome measures

Measure	Arm 1A: Docetaxel Then AC n=199 Participants Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev n=195 Participants Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC n=199 Participants Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev n=193 Participants Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC n=192 Participants Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev n=200 Participants Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens	79.9 percentage of patients Interval 73.6 to 84.8	87.7 percentage of patients Interval 82.2 to 91.6	75.4 percentage of patients Interval 68.8 to 80.8	90.7 percentage of patients Interval 85.6 to 94.0	83.3 percentage of patients Interval 77.3 to 87.9	80.5 percentage of patients Interval 74.3 to 85.4

SECONDARY outcome

Timeframe: Assessed at cycle 5 of chemotherapy, on average at 15 weeks

Population: For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients

Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.

Outcome measures

Measure	Arm 1A: Docetaxel Then AC n=199 Participants Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev n=195 Participants Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC n=199 Participants Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev n=193 Participants Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC n=192 Participants Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev n=200 Participants Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy	30 percentage of patients Interval 23.8 to 36.4	43.3 percentage of patients Interval 36.3 to 50.1	29.8 percentage of patients Interval 23.6 to 36.2	34.5 percentage of patients Interval 27.9 to 41.2	37.9 percentage of patients Interval 31.0 to 44.7	42 percentage of patients Interval 35.1 to 48.7

SECONDARY outcome

Timeframe: Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months

Population: For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients

The percentage of patients assessed by physical exam as Clinical Complete Response according to RECIST.

Outcome measures

Measure	Arm 1A: Docetaxel Then AC n=199 Participants Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev n=195 Participants Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC n=199 Participants Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev n=193 Participants Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC n=192 Participants Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev n=200 Participants Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens	52.3 percentage of patients Interval 45.1 to 58.9	64.6 percentage of patients Interval 57.5 to 70.9	51.3 percentage of patients Interval 44.1 to 57.9	59.1 percentage of patients Interval 51.8 to 65.6	52.6 percentage of patients Interval 45.3 to 59.4	60 percentage of patients Interval 52.9 to 66.4

SECONDARY outcome

Timeframe: After each cycle, 3-5 weeks postoperative, 9 and 12 months from study entry, every 6 month years 2-5, and annually years 6-10, for postoperative bevacizumab patients, every 6 weeks during postoperative therapy and at 18 months following study entry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months after study entry

Population: For Arm 1A there is no follow up data for 8 patients; Arm 1B no follow up data for 8 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 12 patients; Arm 3A no follow up data for 11 patients; Arm 3B no follow up data for 7 patients

Number of patients with Grade 4 or above surgery-related toxicities

Outcome measures

Measure	Arm 1A: Docetaxel Then AC n=193 Participants Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev n=191 Participants Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC n=198 Participants Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev n=189 Participants Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC n=186 Participants Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev n=197 Participants Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Surgical Complication	1 participants	1 participants	0 participants	1 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: 24 months after study entry

Population: For Arm 1A there is no followup data for 2 patients; for Arm 2A there is no followup data for 1 patient; for Arm 3A there is no followup data for 3 patients; for Arm 1B there is no followup data for 3 patients; for Arm 2B there is no followup data for 5 patients; and for Arm 3B there is no followup data for 2 patients.

The number of patients who experienced Grade 1 or above Adverse Events. Referring to the Adverse Events tables for specifics.

Outcome measures

Measure	Arm 1A: Docetaxel Then AC n=199 Participants Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev n=196 Participants Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC n=203 Participants Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev n=196 Participants Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC n=194 Participants Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev n=202 Participants Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone	180 participants	157 participants	172 participants	185 participants	158 participants	185 participants

SECONDARY outcome

Timeframe: Measured through 5 years after study enrollment

Population: For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2B no follow up data for 6 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 3 patients

Percentage of patients free from local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer after 5 years.

Outcome measures

Measure	Arm 1A: Docetaxel Then AC n=199 Participants Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy). cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 1B Docetaxel + Bev Then AC + Bev n=195 Participants Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2A: Docetaxel + Capecitabine Then AC n=204 Participants Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 2B: Docetaxel + Cape + Bev Then AC + Bev n=195 Participants Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV capecitabine: 825 mg/m2 orally cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV	Arm 3A: Docetaxel + Gem Then AC n=190 Participants Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A. cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV	Arm 3B: Docetaxel + Gem + Bev Then AC + Bev n=201 Participants Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B. bevacizumab: 15 mg/kg IV cyclophosphamide: 600 mg/m2 IV docetaxel: 100 mg/m2 IV doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV gemcitabine hydrochloride: 1000 mg/m2 IV
Disease-free Survival (DFS)	73.4 percentage of patients Interval 66.2 to 79.3	72.2 percentage of patients Interval 65.1 to 78.1	68.5 percentage of patients Interval 61.0 to 74.9	77.1 percentage of patients Interval 69.7 to 82.9	72.9 percentage of patients Interval 65.3 to 79.1	74.8 percentage of patients Interval 66.1 to 81.5

Adverse Events

Docetaxel Then AC

Serious events: 4 serious events

Other events: 118 other events

Deaths: 0 deaths

Docetaxel + Bev Then AC + Bev

Serious events: 15 serious events

Other events: 150 other events

Deaths: 0 deaths

Docetaxel + Capecitabine Then AC

Serious events: 8 serious events

Other events: 168 other events

Deaths: 0 deaths

Docetaxel + Cape + Bev Then AC + Bev

Serious events: 30 serious events

Other events: 182 other events

Deaths: 0 deaths

Docetaxel + Gem Then AC

Serious events: 2 serious events

Other events: 150 other events

Deaths: 0 deaths

Docetaxel + Gem + Bev Then AC + Bev

Serious events: 15 serious events

Other events: 178 other events

Deaths: 0 deaths

Serious adverse events

Measure	Docetaxel Then AC n=199 participants at risk Docetaxel then AC	Docetaxel + Bev Then AC + Bev n=196 participants at risk Docetaxel + Bev then AC + Bev	Docetaxel + Capecitabine Then AC n=203 participants at risk Docetaxel + Capecitabine then AC	Docetaxel + Cape + Bev Then AC + Bev n=196 participants at risk Docetaxel + Cape + Bev then AC + Bev	Docetaxel + Gem Then AC n=194 participants at risk Docetaxel + Gem then AC	Docetaxel + Gem + Bev Then AC + Bev n=202 participants at risk Docetaxel + Gem + Bev then AC + Bev
Gastrointestinal disorders Abdominal pain	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Immune system disorders Anaphylaxis	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Anemia	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Anxiety	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Cardiac arrest	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Investigations Cardiac troponin I increased	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Colonic hemorrhage	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Colonic perforation	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Investigations Creatinine increased	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.52% 1/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Dehydration	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.99% 2/202 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Depression	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	1.0% 2/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Endocarditis infective	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Headache	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Heart failure	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperkalemia	0.50% 1/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Hypertension	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypokalemia	1.0% 2/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	1.0% 2/196 Participants at Risk includes any patient who submitted an AE form.	0.52% 1/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.52% 1/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Investigations Investigations - Other, specify	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Myocardial infarction	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.99% 2/202 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Pericardial effusion	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Proteinuria	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	2.0% 4/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Sepsis	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
General disorders Sudden death NOS	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Thromboembolic event	0.50% 1/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.99% 2/203 Participants at Risk includes any patient who submitted an AE form.	2.0% 4/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Reproductive system and breast disorders Uterine hemorrhage	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	1.0% 2/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	1.5% 3/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.99% 2/202 Participants at Risk includes any patient who submitted an AE form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia secondary to oncology chemotherapy	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Visceral arterial ischemia	0.50% 1/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Anal hemorrhage	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Abdominal infection	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/202 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Lung infection	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.50% 1/202 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	0.51% 1/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	2.6% 5/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	0.99% 2/202 Participants at Risk includes any patient who submitted an AE form.

Other adverse events

Measure	Docetaxel Then AC n=199 participants at risk Docetaxel then AC	Docetaxel + Bev Then AC + Bev n=196 participants at risk Docetaxel + Bev then AC + Bev	Docetaxel + Capecitabine Then AC n=203 participants at risk Docetaxel + Capecitabine then AC	Docetaxel + Cape + Bev Then AC + Bev n=196 participants at risk Docetaxel + Cape + Bev then AC + Bev	Docetaxel + Gem Then AC n=194 participants at risk Docetaxel + Gem then AC	Docetaxel + Gem + Bev Then AC + Bev n=202 participants at risk Docetaxel + Gem + Bev then AC + Bev
Investigations Alanine aminotransferase increased (ALT/SGPT)	1.0% 2/199 Participants at Risk includes any patient who submitted an AE form.	4.6% 9/196 Participants at Risk includes any patient who submitted an AE form.	4.9% 10/203 Participants at Risk includes any patient who submitted an AE form.	3.6% 7/196 Participants at Risk includes any patient who submitted an AE form.	13.4% 26/194 Participants at Risk includes any patient who submitted an AE form.	17.3% 35/202 Participants at Risk includes any patient who submitted an AE form.
Investigations Aspartate aminotransferase increased (AST/SGOT)	1.5% 3/199 Participants at Risk includes any patient who submitted an AE form.	3.6% 7/196 Participants at Risk includes any patient who submitted an AE form.	2.5% 5/203 Participants at Risk includes any patient who submitted an AE form.	4.1% 8/196 Participants at Risk includes any patient who submitted an AE form.	9.3% 18/194 Participants at Risk includes any patient who submitted an AE form.	13.4% 27/202 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Bone pain	5.0% 10/199 Participants at Risk includes any patient who submitted an AE form.	8.2% 16/196 Participants at Risk includes any patient who submitted an AE form.	0.49% 1/203 Participants at Risk includes any patient who submitted an AE form.	3.6% 7/196 Participants at Risk includes any patient who submitted an AE form.	3.1% 6/194 Participants at Risk includes any patient who submitted an AE form.	2.0% 4/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Diarrhea	13.1% 26/199 Participants at Risk includes any patient who submitted an AE form.	13.8% 27/196 Participants at Risk includes any patient who submitted an AE form.	25.6% 52/203 Participants at Risk includes any patient who submitted an AE form.	21.9% 43/196 Participants at Risk includes any patient who submitted an AE form.	21.1% 41/194 Participants at Risk includes any patient who submitted an AE form.	21.3% 43/202 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.5% 11/199 Participants at Risk includes any patient who submitted an AE form.	5.1% 10/196 Participants at Risk includes any patient who submitted an AE form.	2.5% 5/203 Participants at Risk includes any patient who submitted an AE form.	4.6% 9/196 Participants at Risk includes any patient who submitted an AE form.	5.7% 11/194 Participants at Risk includes any patient who submitted an AE form.	6.9% 14/202 Participants at Risk includes any patient who submitted an AE form.
General disorders Fatigue	9.0% 18/199 Participants at Risk includes any patient who submitted an AE form.	9.2% 18/196 Participants at Risk includes any patient who submitted an AE form.	10.3% 21/203 Participants at Risk includes any patient who submitted an AE form.	10.7% 21/196 Participants at Risk includes any patient who submitted an AE form.	7.2% 14/194 Participants at Risk includes any patient who submitted an AE form.	10.9% 22/202 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Febrile neutropenia	2.5% 5/199 Participants at Risk includes any patient who submitted an AE form.	9.2% 18/196 Participants at Risk includes any patient who submitted an AE form.	6.9% 14/203 Participants at Risk includes any patient who submitted an AE form.	11.7% 23/196 Participants at Risk includes any patient who submitted an AE form.	8.2% 16/194 Participants at Risk includes any patient who submitted an AE form.	9.4% 19/202 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Headache	0.50% 1/199 Participants at Risk includes any patient who submitted an AE form.	3.6% 7/196 Participants at Risk includes any patient who submitted an AE form.	0.99% 2/203 Participants at Risk includes any patient who submitted an AE form.	3.6% 7/196 Participants at Risk includes any patient who submitted an AE form.	1.0% 2/194 Participants at Risk includes any patient who submitted an AE form.	5.4% 11/202 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperglycemia	5.5% 11/199 Participants at Risk includes any patient who submitted an AE form.	1.5% 3/196 Participants at Risk includes any patient who submitted an AE form.	3.0% 6/203 Participants at Risk includes any patient who submitted an AE form.	1.5% 3/196 Participants at Risk includes any patient who submitted an AE form.	2.6% 5/194 Participants at Risk includes any patient who submitted an AE form.	2.5% 5/202 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Hypertension	2.0% 4/199 Participants at Risk includes any patient who submitted an AE form.	25.0% 49/196 Participants at Risk includes any patient who submitted an AE form.	1.5% 3/203 Participants at Risk includes any patient who submitted an AE form.	21.9% 43/196 Participants at Risk includes any patient who submitted an AE form.	1.0% 2/194 Participants at Risk includes any patient who submitted an AE form.	24.3% 49/202 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Infections and infestations - Other, specify	2.0% 4/199 Participants at Risk includes any patient who submitted an AE form.	5.6% 11/196 Participants at Risk includes any patient who submitted an AE form.	3.9% 8/203 Participants at Risk includes any patient who submitted an AE form.	8.2% 16/196 Participants at Risk includes any patient who submitted an AE form.	3.6% 7/194 Participants at Risk includes any patient who submitted an AE form.	9.9% 20/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Mucositis oral	11.1% 22/199 Participants at Risk includes any patient who submitted an AE form.	27.6% 54/196 Participants at Risk includes any patient who submitted an AE form.	27.6% 56/203 Participants at Risk includes any patient who submitted an AE form.	42.3% 83/196 Participants at Risk includes any patient who submitted an AE form.	19.6% 38/194 Participants at Risk includes any patient who submitted an AE form.	28.7% 58/202 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Myalgia	5.0% 10/199 Participants at Risk includes any patient who submitted an AE form.	4.6% 9/196 Participants at Risk includes any patient who submitted an AE form.	1.5% 3/203 Participants at Risk includes any patient who submitted an AE form.	5.6% 11/196 Participants at Risk includes any patient who submitted an AE form.	2.1% 4/194 Participants at Risk includes any patient who submitted an AE form.	1.5% 3/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Nausea	2.0% 4/199 Participants at Risk includes any patient who submitted an AE form.	4.6% 9/196 Participants at Risk includes any patient who submitted an AE form.	3.9% 8/203 Participants at Risk includes any patient who submitted an AE form.	5.1% 10/196 Participants at Risk includes any patient who submitted an AE form.	6.7% 13/194 Participants at Risk includes any patient who submitted an AE form.	4.5% 9/202 Participants at Risk includes any patient who submitted an AE form.
Investigations Neutrophil count decreased	14.1% 28/199 Participants at Risk includes any patient who submitted an AE form.	15.3% 30/196 Participants at Risk includes any patient who submitted an AE form.	20.7% 42/203 Participants at Risk includes any patient who submitted an AE form.	18.9% 37/196 Participants at Risk includes any patient who submitted an AE form.	33.0% 64/194 Participants at Risk includes any patient who submitted an AE form.	34.7% 70/202 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Peripheral motor neuropathy	4.0% 8/199 Participants at Risk includes any patient who submitted an AE form.	2.0% 4/196 Participants at Risk includes any patient who submitted an AE form.	1.5% 3/203 Participants at Risk includes any patient who submitted an AE form.	6.6% 13/196 Participants at Risk includes any patient who submitted an AE form.	2.1% 4/194 Participants at Risk includes any patient who submitted an AE form.	2.0% 4/202 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Peripheral sensory neuropathy	16.6% 33/199 Participants at Risk includes any patient who submitted an AE form.	17.9% 35/196 Participants at Risk includes any patient who submitted an AE form.	14.3% 29/203 Participants at Risk includes any patient who submitted an AE form.	20.4% 40/196 Participants at Risk includes any patient who submitted an AE form.	9.8% 19/194 Participants at Risk includes any patient who submitted an AE form.	10.4% 21/202 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Proteinuria	0.00% 0/199 Participants at Risk includes any patient who submitted an AE form.	6.1% 12/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/203 Participants at Risk includes any patient who submitted an AE form.	2.6% 5/196 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/194 Participants at Risk includes any patient who submitted an AE form.	5.0% 10/202 Participants at Risk includes any patient who submitted an AE form.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 22/199 Participants at Risk includes any patient who submitted an AE form.	11.2% 22/196 Participants at Risk includes any patient who submitted an AE form.	5.4% 11/203 Participants at Risk includes any patient who submitted an AE form.	14.8% 29/196 Participants at Risk includes any patient who submitted an AE form.	17.0% 33/194 Participants at Risk includes any patient who submitted an AE form.	18.8% 38/202 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Vomiting	3.0% 6/199 Participants at Risk includes any patient who submitted an AE form.	2.0% 4/196 Participants at Risk includes any patient who submitted an AE form.	4.4% 9/203 Participants at Risk includes any patient who submitted an AE form.	3.6% 7/196 Participants at Risk includes any patient who submitted an AE form.	8.2% 16/194 Participants at Risk includes any patient who submitted an AE form.	4.0% 8/202 Participants at Risk includes any patient who submitted an AE form.
Investigations White blood cell decreased	3.0% 6/199 Participants at Risk includes any patient who submitted an AE form.	7.1% 14/196 Participants at Risk includes any patient who submitted an AE form.	6.9% 14/203 Participants at Risk includes any patient who submitted an AE form.	3.6% 7/196 Participants at Risk includes any patient who submitted an AE form.	11.3% 22/194 Participants at Risk includes any patient who submitted an AE form.	7.9% 16/202 Participants at Risk includes any patient who submitted an AE form.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	6.5% 13/199 Participants at Risk includes any patient who submitted an AE form.	16.3% 32/196 Participants at Risk includes any patient who submitted an AE form.	45.3% 92/203 Participants at Risk includes any patient who submitted an AE form.	56.1% 110/196 Participants at Risk includes any patient who submitted an AE form.	2.6% 5/194 Participants at Risk includes any patient who submitted an AE form.	6.9% 14/202 Participants at Risk includes any patient who submitted an AE form.

Additional Information

Director, Department of Regulatory Affairs

NSABP Foundation, Inc

Phone: 412-339-5300

Email: regulatory@nsabp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60