Clinical trial NCT02978495: Neoadjuvant Carboplatin in Triple Negative Breast Cancer
Official title: Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: BRCA1 Hereditary Breast and Ovarian Cancer Syndrome
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.
timeFrame: within the first 21 days after surgery
Secondary outcomes:
measure: Disease free survival (DFS)
timeFrame: within the first 60 month after surgery
measure: Overall survival (OS)
timeFrame: within the first 60 month after surgery
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: SP
Study officials:
References:
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