Neoadjuvant Carboplatin in Triple Negative Breast Cancer

Phase 2

Completed

• Conditions: BRCA1 Hereditary Breast and Ovarian Cancer Syndrome
• Interventions: Drug: Doxorubicin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cyclophosphamide

• Registration Number: NCT02978495
• Lead Sponsor: Barretos Cancer Hospital

Brief Summary

Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a prospective, randomized, open-label, phase II study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-12-01
• Study Start: 2017-05-17
• Primary Completion: 2019-12-02
• Study Completion: 2021-10-22
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-25
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

• Triple Negative Breast Cancer;
• Stage II or III;
• Performance Status ECOG <2 or Karnofsky >50%;
• Hematologic (minimal values):

Absolute neutrophil count > 1,500/mm3 Hemoglobin > 10.0 g/dl Platelet count > 100,000/mm3

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Exclusion Criteria

• Stage I or IV;
• other malignancies.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A- BRCA Mutation	Doxorubicin	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
A- BRCA Mutation	Carboplatin	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
A- BRCA Mutation	Paclitaxel	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
A- BRCA Mutation	Cyclophosphamide	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
D- BRCA wild-type	Doxorubicin	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.
D- BRCA wild-type	Paclitaxel	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.
D- BRCA wild-type	Cyclophosphamide	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.
B- BRCA Mutation	Doxorubicin	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.
C- BRCA wild-type	Paclitaxel	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
B- BRCA Mutation	Cyclophosphamide	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.
B- BRCA Mutation	Paclitaxel	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.
C- BRCA wild-type	Doxorubicin	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
C- BRCA wild-type	Carboplatin	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
C- BRCA wild-type	Cyclophosphamide	1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.	within the first 21 days after surgery

Secondary Outcome Measures

Name	Time	Method
Disease free survival (DFS)	within the first 60 month after surgery
Overall survival (OS)	within the first 60 month after surgery

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, SP, Brazil