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OpenTrials
Completed

NCT Number: NCT02978495

Neoadjuvant Carboplatin in Triple Negative Breast Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Barretos Cancer Hospital

Barretos, São Paulo, 14784-400, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Stage I or IV;
  • other malignancies.

Treatment and study plan

Doxorubicin

Drug

Doxorrubicin 60 mg/m2 4 cycles each 21 days

carboplatin

Drug

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

paclitaxel

Drug

80mg/m2 weekly for 12 weeks

Cyclophosphamide

Drug

600mg/m2 4 cycles each 21 days

Primary outcomes

  1. Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.

    Time frame: within the first 21 days after surgery

Secondary outcomes

  1. Disease free survival (DFS)

    Time frame: within the first 60 month after surgery

  2. Overall survival (OS)

    Time frame: within the first 60 month after surgery

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Registry information

Official study title

Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Dec 1, 2016
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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