Trial Outcomes & Findings for Fasting on Newly Diagnosed Breast Cancer (NCT NCT02379585)

Results Overview

Evaluate pathological complete remission rate at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

4-6 cycles (up to 12 weeks)

Results posted on

2018-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnosed With HER2 Negative Breast Cancer Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three-six weeks after completing the last cycle of paclitaxel. Doxorubicin: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20 cyclophosphamide: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20 paclitaxel: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (	Diagnosed With HER2 Positive Breast Cancer will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year docetaxel: For patients with HER2 positive breast cancer: docetaxel 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles be
Overall Study STARTED	3	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fasting on Newly Diagnosed Breast Cancer

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 4-6 cycles (up to 12 weeks)

Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information. After much effort, results were not able to be retained.

Evaluate pathological complete remission rate at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy.