Trial Outcomes & Findings for Phase II Trial for Large ER-Negative Breast Cancers (NCT NCT01869192)

NCT ID: NCT01869192

Last Updated: 2019-09-24

Results Overview

To describe the overall response rate as measured by physical exam and MRI if indicated using the following definition: Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 72 participants
• Primary outcome timeframe: Up to 8 months
• Results posted on: 2019-09-24

Participant Flow

Participant milestones

Measure	Arm A: EC Prior to Surgery, Then XT Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Epirubicin: Epirubicin 90 mg/m2 d1 q3w Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w Radiation Therapy: Standard dosing, fields depending on clinical findings	Arm B: XT Prior to Surgery, Then EC Arm B: Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then surgery, then Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Docetaxel: Docetaxel 75 mg/m2 d1 q3w Capecitabine: Capecitabine 1000 mg/m2/dose bid x 14d q3w Radiation Therapy: Standard dosing, fields depending on clinical findings
Preoperative Chemotherapy to Surgery STARTED	37	35
Preoperative Chemotherapy to Surgery COMPLETED	35	34
Preoperative Chemotherapy to Surgery NOT COMPLETED	2	1
Postoperative Chemotherapy STARTED	32	33
Postoperative Chemotherapy COMPLETED	32	31
Postoperative Chemotherapy NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Arm A: EC Prior to Surgery, Then XT Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Epirubicin: Epirubicin 90 mg/m2 d1 q3w Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w Radiation Therapy: Standard dosing, fields depending on clinical findings	Arm B: XT Prior to Surgery, Then EC Arm B: Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then surgery, then Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Docetaxel: Docetaxel 75 mg/m2 d1 q3w Capecitabine: Capecitabine 1000 mg/m2/dose bid x 14d q3w Radiation Therapy: Standard dosing, fields depending on clinical findings
Preoperative Chemotherapy to Surgery patient choice	2	1
Postoperative Chemotherapy Physician Decision	0	2

Baseline Characteristics

Phase II Trial for Large ER-Negative Breast Cancers

Baseline characteristics by cohort

Measure	Arm A n=37 Participants Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Epirubicin: Epirubicin 90 mg/m2 d1 q3w Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w Radiation Therapy: Standard dosing, fields depending on clinical findings	Arm B n=35 Participants Arm B: Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then surgery, then Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Docetaxel: Docetaxel 75 mg/m2 d1 q3w Capecitabine: Capecitabine 1000 mg/m2/dose bid x 14d q3w Radiation Therapy: Standard dosing, fields depending on clinical findings	Total n=72 Participants Total of all reporting groups
Age, Continuous	50 years n=5 Participants	50 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	35 Participants n=7 Participants	72 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 8 months

To describe the overall response rate as measured by physical exam and MRI if indicated using the following definition: Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Arm A n=37 Participants Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Epirubicin: Epirubicin 90 mg/m2 d1 q3w Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w Radiation Therapy: Standard dosing, fields depending on clinical findings	Arm B n=35 Participants Arm B: Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then surgery, then Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Docetaxel: Docetaxel 75 mg/m2 d1 q3w Capecitabine: Capecitabine 1000 mg/m2/dose bid x 14d q3w Radiation Therapy: Standard dosing, fields depending on clinical findings
Overall Response Rate	25 Participants	21 Participants

SECONDARY outcome

Timeframe: Up to 8 months

Pathological response (pCR or microscopic only primary) in both primary and nodes using the Miller-Payne criteria for pathologic response.

Outcome measures

Measure	Arm A n=37 Participants Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Epirubicin: Epirubicin 90 mg/m2 d1 q3w Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w Radiation Therapy: Standard dosing, fields depending on clinical findings	Arm B n=35 Participants Arm B: Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then surgery, then Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment Docetaxel: Docetaxel 75 mg/m2 d1 q3w Capecitabine: Capecitabine 1000 mg/m2/dose bid x 14d q3w Radiation Therapy: Standard dosing, fields depending on clinical findings
Pathological Response	2 Participants	8 Participants

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Elias, MD

University of Colorado

Phone: 17208480347

Email: anthony.elias@ucdenver.edu

Results disclosure agreements

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