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Neoadjuvant Carboplatin in Triple Negative Breast Cancer

NCT02978495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2022-12-28

No results posted yet for this study

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.

Conditions

  • BRCA1 Hereditary Breast and Ovarian Cancer Syndrome

Interventions

DRUG

Doxorubicin

Doxorrubicin 60 mg/m2 4 cycles each 21 days

DRUG

Carboplatin

Carboplatin AUC 1,5 once a week, for 12 weeks

DRUG

Paclitaxel

80mg/m2 weekly for 12 weeks

DRUG

Cyclophosphamide

600mg/m2 4 cycles each 21 days

Sponsors & Collaborators

  • Barretos Cancer Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2019-12-02
Completion
2021-10-22

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02978495 on ClinicalTrials.gov