Neoadjuvant Carboplatin in Triple Negative Breast Cancer

  • STATUS
    Recruiting
  • End date
    Dec 23, 2022
  • participants needed
    120
  • sponsor
    Barretos Cancer Hospital
Updated on 23 January 2021

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.

Details
Condition BRCA1 Hereditary Breast and Ovarian Cancer Syndrome
Treatment cyclophosphamide, carboplatin, Paclitaxel, doxorubicin
Clinical Study IdentifierNCT02978495
SponsorBarretos Cancer Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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 >
000/mm3

Exclusion Criteria

Stage I or IV
other malignancies
Clear my responses

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