Trial Outcomes & Findings for Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (NCT NCT02003209)
NCT ID: NCT02003209
Last Updated: 2025-08-08
Results Overview
Proportion of patients with pCR evaluated histologically, and defined as the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
315 participants
Primary outcome timeframe
Up to 2.8 years (when all patients completed primary breast surgery)
Results posted on
2025-08-08
Participant Flow
Participant milestones
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Aromatase Inhibition Therapy: Given at the investigator's discretion
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
157
|
|
Overall Study
COMPLETED
|
153
|
155
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Aromatase Inhibition Therapy: Given at the investigator's discretion
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
|---|---|---|
|
Overall Study
Patient not at risk for primary endpoint
|
5
|
2
|
Baseline Characteristics
Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
n=158 Participants
Arm I (combination chemotherapy, surgery, radiation)
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
n=157 Participants
Arm II (chemo, estrogen deprivation, surgery, radiation)
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
50 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
50 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2.8 years (when all patients completed primary breast surgery)Proportion of patients with pCR evaluated histologically, and defined as the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
n=153 Participants
NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
n=155 Participants
NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Aromatase Inhibition Therapy: Given at the investigator's discretion
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
|---|---|---|
|
Percent of Patients With Pathological Complete Response (pCR) in the Breast and Post Therapy Lymph Nodes
|
41.2 percentage of participants
|
45.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2.8 years (when all patients completed primary breast surgery)Proportion of patients with pCR in the breast, defined as the absence of any invasive component in the resected breast specimen.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
n=153 Participants
NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
n=155 Participants
NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Aromatase Inhibition Therapy: Given at the investigator's discretion
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
|---|---|---|
|
Percent of Patients With Pathologic Complete Response (pCR) in the Breast
|
44.4 percentage of participants
|
47.1 percentage of participants
|
SECONDARY outcome
Timeframe: Time from surgery to invasive local, regional or distant recurrence, or death from breast cancer for patients with operable disease and for patients with inoperable progressive disease, assessed up to 8.4 yearsKaplan-Meier estimates of the percentages of patients free from recurrence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from randomization until death from any cause, assessed up to 8.4 yearsKaplan-Meier estimates of the percentages of patients surviving.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from randomization to the development of a second primary invasive cancer of any site excluding squamous and basal cell carcinoma of the skin, assessed up to 8.4 yearsThe cumulative incidence rates of second primary cancers for the two treatment groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.8 years (when all patients completed primary breast surgery)Population: Includes all patients that reported a primary breast cancer surgery.
Proportion of patients with pCR evaluated histologically, and defined as the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy calculated separately for premenopausal and postmenopausal women.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
n=153 Participants
NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
n=155 Participants
NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Aromatase Inhibition Therapy: Given at the investigator's discretion
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
|---|---|---|
|
Percent of Patients With Pathological Complete Response (pCR) in the Breast and Post Therapy Lymph Nodes by Menopausal Status
Premenopausal Women
|
44.2 percentage of participants with pCR
|
46.2 percentage of participants with pCR
|
|
Percent of Patients With Pathological Complete Response (pCR) in the Breast and Post Therapy Lymph Nodes by Menopausal Status
Postmenopausal Women
|
38.2 percentage of participants with pCR
|
45.5 percentage of participants with pCR
|
SECONDARY outcome
Timeframe: Up to 5 yearsKaplan -Meier estimates of the percentages of patients free from recurrence by menopausal status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsKaplan-Meier estimates of the percentages of patients surviving by menopausal status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 weeks post surgeryPopulation: Includes all patients that submitted an AE form.
Percentage of patients with grade 1 or higher toxicity from the Cardiac Disorders System Organ Class.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
n=157 Participants
NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
n=157 Participants
NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Aromatase Inhibition Therapy: Given at the investigator's discretion
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
|---|---|---|
|
Percentage of Participants With Cardiac Toxicity Categorized According to National Cancer Institute CTCAE Version 4.0
|
4.46 percentage of pts with cardiac toxicity
|
4.46 percentage of pts with cardiac toxicity
|
SECONDARY outcome
Timeframe: 2.8 yearsPopulation: Includes patients with adequate tissue for assessment of sTILs.
Percentage of Tumor-infiltrating lymphocytes present in the stroma in tissue specimen.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
n=119 Participants
NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
n=127 Participants
NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment.
SURGERY: Patients undergo lumpectomy or mastectomy.
RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery.
ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Aromatase Inhibition Therapy: Given at the investigator's discretion
Carboplatin: Given IV
Cytology Specimen Collection Procedure: Undergo 2 core biopsies
Docetaxel: Given IV
Goserelin Acetate: Given SC
Laboratory Biomarker Analysis: Correlative studies
Pertuzumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Therapeutic Conventional Surgery: Undergo lumpectomy or mastectomy
Trastuzumab: Given IV
Whole Breast Irradiation: Undergo whole breast irradiation
|
|---|---|---|
|
Median Percentage of Tumor-infiltrating Lymphocytes (sTILS)
No pCR
|
10 percentage of TILs
Interval 5.0 to 20.0
|
10 percentage of TILs
Interval 0.0 to 20.0
|
|
Median Percentage of Tumor-infiltrating Lymphocytes (sTILS)
pCR
|
10 percentage of TILs
Interval 5.0 to 30.0
|
10 percentage of TILs
Interval 5.0 to 22.5
|
SECONDARY outcome
Timeframe: Baseline to up to 4 weeks after the last dose of chemotherapyMean total score from the BCPT symptom checklist calculated as the average severity score across all items at each timepoint.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Combination Chemotherapy, Surgery, Radiation)
Serious events: 36 serious events
Other events: 151 other events
Deaths: 0 deaths
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
Serious events: 35 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
n=158 participants at risk
Arm I (combination chemotherapy, surgery, radiation)
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
n=157 participants at risk
Arm II (chemo, estrogen deprivation, surgery, radiation)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
5/158
Participants at Risk includes any patient who submitted an AE form.
|
3.8%
6/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Appendicitis
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Bladder infection
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Catheter related infection
|
1.3%
2/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
1.3%
2/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Colitis
|
1.3%
2/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Constipation
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
9/158
Participants at Risk includes any patient who submitted an AE form.
|
3.2%
5/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Diarrhea
|
6.3%
10/158
Participants at Risk includes any patient who submitted an AE form.
|
8.3%
13/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Dizziness
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Fatigue
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Gastritis
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Hypertension
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.1%
8/158
Participants at Risk includes any patient who submitted an AE form.
|
3.2%
5/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
1.9%
3/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.5%
4/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.3%
2/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.9%
3/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
10/158
Participants at Risk includes any patient who submitted an AE form.
|
3.8%
6/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Platelet count decreased
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Sinus tachycardia
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Skin infection
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
1.3%
2/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Syncope
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
1.3%
2/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Thromboembolic event
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
1.3%
2/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
4/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Vaginal infection
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Ear and labyrinth disorders
Vertigo
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
8/158
Participants at Risk includes any patient who submitted an AE form.
|
3.8%
6/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Ejection fraction decreased
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Enterocolitis infectious
|
1.9%
3/158
Participants at Risk includes any patient who submitted an AE form.
|
2.5%
4/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Lung infection
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Mucosal infection
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Vulval infection
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
3/158
Participants at Risk includes any patient who submitted an AE form.
|
0.64%
1/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.63%
1/158
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/157
Participants at Risk includes any patient who submitted an AE form.
|
Other adverse events
| Measure |
Arm I (Combination Chemotherapy, Surgery, Radiation)
n=158 participants at risk
Arm I (combination chemotherapy, surgery, radiation)
|
Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation)
n=157 participants at risk
Arm II (chemo, estrogen deprivation, surgery, radiation)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
7/158
Participants at Risk includes any patient who submitted an AE form.
|
7.6%
12/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Alanine aminotransferase increased (ALT/SGPT)
|
5.1%
8/158
Participants at Risk includes any patient who submitted an AE form.
|
3.2%
5/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
41.8%
66/158
Participants at Risk includes any patient who submitted an AE form.
|
38.2%
60/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Blood and lymphatic system disorders
Anemia
|
47.5%
75/158
Participants at Risk includes any patient who submitted an AE form.
|
43.9%
69/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.0%
19/158
Participants at Risk includes any patient who submitted an AE form.
|
14.6%
23/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
10/158
Participants at Risk includes any patient who submitted an AE form.
|
8.9%
14/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
8/158
Participants at Risk includes any patient who submitted an AE form.
|
8.9%
14/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Constipation
|
7.0%
11/158
Participants at Risk includes any patient who submitted an AE form.
|
4.5%
7/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Creatinine increased
|
5.7%
9/158
Participants at Risk includes any patient who submitted an AE form.
|
3.2%
5/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Dehydration
|
29.7%
47/158
Participants at Risk includes any patient who submitted an AE form.
|
22.3%
35/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Diarrhea
|
58.9%
93/158
Participants at Risk includes any patient who submitted an AE form.
|
57.3%
90/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Dysgeusia
|
11.4%
18/158
Participants at Risk includes any patient who submitted an AE form.
|
10.8%
17/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
9/158
Participants at Risk includes any patient who submitted an AE form.
|
8.9%
14/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.6%
12/158
Participants at Risk includes any patient who submitted an AE form.
|
5.1%
8/157
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Fatigue
|
44.3%
70/158
Participants at Risk includes any patient who submitted an AE form.
|
47.1%
74/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.1%
8/158
Participants at Risk includes any patient who submitted an AE form.
|
8.3%
13/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Headache
|
6.3%
10/158
Participants at Risk includes any patient who submitted an AE form.
|
7.0%
11/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Hot flashes
|
7.6%
12/158
Participants at Risk includes any patient who submitted an AE form.
|
7.0%
11/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.6%
12/158
Participants at Risk includes any patient who submitted an AE form.
|
6.4%
10/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Hypertension
|
16.5%
26/158
Participants at Risk includes any patient who submitted an AE form.
|
16.6%
26/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.1%
8/158
Participants at Risk includes any patient who submitted an AE form.
|
5.7%
9/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.5%
26/158
Participants at Risk includes any patient who submitted an AE form.
|
19.1%
30/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.3%
10/158
Participants at Risk includes any patient who submitted an AE form.
|
8.9%
14/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.4%
7/158
Participants at Risk includes any patient who submitted an AE form.
|
8.9%
14/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Insomnia
|
8.2%
13/158
Participants at Risk includes any patient who submitted an AE form.
|
4.5%
7/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Lymphocyte count decreased
|
7.0%
11/158
Participants at Risk includes any patient who submitted an AE form.
|
5.7%
9/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Mucositis oral
|
18.4%
29/158
Participants at Risk includes any patient who submitted an AE form.
|
15.9%
25/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
13/158
Participants at Risk includes any patient who submitted an AE form.
|
7.6%
12/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Nausea
|
38.6%
61/158
Participants at Risk includes any patient who submitted an AE form.
|
35.7%
56/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Neutrophil count decreased
|
13.9%
22/158
Participants at Risk includes any patient who submitted an AE form.
|
8.9%
14/157
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Pain
|
3.2%
5/158
Participants at Risk includes any patient who submitted an AE form.
|
10.8%
17/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.1%
16/158
Participants at Risk includes any patient who submitted an AE form.
|
15.9%
25/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Platelet count decreased
|
12.0%
19/158
Participants at Risk includes any patient who submitted an AE form.
|
12.7%
20/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Urinary tract infection
|
8.9%
14/158
Participants at Risk includes any patient who submitted an AE form.
|
12.1%
19/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Vomiting
|
18.4%
29/158
Participants at Risk includes any patient who submitted an AE form.
|
17.2%
27/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Weight loss
|
8.2%
13/158
Participants at Risk includes any patient who submitted an AE form.
|
8.3%
13/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
White blood cell decreased
|
7.0%
11/158
Participants at Risk includes any patient who submitted an AE form.
|
8.3%
13/157
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Edema limbs
|
1.3%
2/158
Participants at Risk includes any patient who submitted an AE form.
|
7.0%
11/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Ejection fraction decreased
|
8.2%
13/158
Participants at Risk includes any patient who submitted an AE form.
|
3.8%
6/157
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Infusion related reaction
|
1.9%
3/158
Participants at Risk includes any patient who submitted an AE form.
|
8.3%
13/157
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.8%
6/158
Participants at Risk includes any patient who submitted an AE form.
|
5.1%
8/157
Participants at Risk includes any patient who submitted an AE form.
|
Additional Information
Judy Langer, Director of Regulatory Affairs
NSABP Foundation
Phone: 412-339-5300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60