Trial Outcomes & Findings for Preoperative Cisplatin and Bevacizumab in ER-, PR-, HER2 Negative Breast Cancer (NCT NCT00580333)

Results Overview

The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

2 years

Results posted on

2021-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	Cisplatin/Avastin cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Cisplatin and Bevacizumab in ER-, PR-, HER2 Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cisplatin/Avastin n=51 Participants Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional) cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles bevacizumab: Preoperatively: Given IV on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)
Age, Continuous	50 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.

Outcome measures

Outcome measures
Measure	Cisplatin/Avastin n=51 Participants Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional) cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week
Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.	16 percentage of participants Interval 7.0 to 29.0

SECONDARY outcome

Timeframe: 2 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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

Outcome measures
Measure	Cisplatin/Avastin n=51 Participants Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional) cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week
Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab CR	12 Participants
Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab OR = CR+PR	39 Participants

SECONDARY outcome

Timeframe: 2 years

Population: analyzed the 43 patients who completed 4 cycles of neoadjuvant therapy and started post-operative treatment

Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons.

Outcome measures

Outcome measures
Measure	Cisplatin/Avastin n=43 Participants Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional) cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week
Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy.	8 Participants

SECONDARY outcome

Timeframe: 2 years

To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response (pCR) in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. A Miller-Payne (MP) score of 3 indicates a decrease in the size of the cancer by 30% to 90%. A MP score of 4 indicates marked decrease in the size of the cancer by greater than 90%. A MP score of 5 indicates there is no residual cancer remaining (the same as a pathologic complete response).

Outcome measures

Outcome measures
Measure	Cisplatin/Avastin n=51 Participants Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional) cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week
Patients With Miller-Payne (MP) Score 3, 4, or 5 Response	45 percentage of participants Interval 31.0 to 60.0

Adverse Events

Cisplatin/Avastin

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cisplatin/Avastin n=51 participants at risk Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional) cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week
General disorders fatigue	70.6% 36/51
Gastrointestinal disorders nausea	68.6% 35/51

Additional Information

Dr. Steven Isakoff

Massachusetts General Hospital

Phone: 617 726 6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place