BRCA1 Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial
Official title:
Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).
| Verified date | December 2022 |
| Source | Barretos Cancer Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 154 |
| Est. completion date | October 22, 2021 |
| Est. primary completion date | December 2, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Barretos Cancer Hospital | Barretos | SP |
| Lead Sponsor | Collaborator |
|---|---|
| Barretos Cancer Hospital |
Brazil,
Arun B, Bayraktar S, Liu DD, Gutierrez Barrera AM, Atchley D, Pusztai L, Litton JK, Valero V, Meric-Bernstam F, Hortobagyi GN, Albarracin C. Response to neoadjuvant systemic therapy for breast cancer in BRCA mutation carriers and noncarriers: a single-ins — View Citation
Byrski T, Gronwald J, Huzarski T, Grzybowska E, Budryk M, Stawicka M, Mierzwa T, Szwiec M, Wisniowski R, Siolek M, Dent R, Lubinski J, Narod S. Pathologic complete response rates in young women with BRCA1-positive breast cancers after neoadjuvant chemothe — View Citation
Gerber B, Loibl S, Eidtmann H, Rezai M, Fasching PA, Tesch H, Eggemann H, Schrader I, Kittel K, Hanusch C, Kreienberg R, Solbach C, Jackisch C, Kunz G, Blohmer JU, Huober J, Hauschild M, Nekljudova V, Untch M, von Minckwitz G; German Breast Group Investig — View Citation
Gonzalez-Angulo AM, Timms KM, Liu S, Chen H, Litton JK, Potter J, Lanchbury JS, Stemke-Hale K, Hennessy BT, Arun BK, Hortobagyi GN, Do KA, Mills GB, Meric-Bernstam F. Incidence and outcome of BRCA mutations in unselected patients with triple receptor-nega — View Citation
Muendlein A, Rohde BH, Gasser K, Haid A, Rauch S, Kinz E, Drexel H, Hofmann W, Schindler V, Kapoor R, Decker T, Lang AH. Evaluation of BRCA1/2 mutational status among German and Austrian women with triple-negative breast cancer. J Cancer Res Clin Oncol. 2 — View Citation
Paluch-Shimon S, Friedman E, Berger R, Papa M, Dadiani M, Friedman N, Shabtai M, Zippel D, Gutman M, Golan T, Yosepovich A, Catane R, Modiano T, Kaufman B. Neo-adjuvant doxorubicin and cyclophosphamide followed by paclitaxel in triple-negative breast canc — View Citation
Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once- — View Citation
Valsecchi ME, Kimmey G, Bir A, Silbermins D. Role of Carboplatin in the Treatment of Triple Negative Early- Stage Breast Cancer. Rev Recent Clin Trials. 2015;10(2):101-10. doi: 10.2174/1574887110666150624101343. — View Citation
von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Disease free survival (DFS) | within the first 60 month after surgery | ||
| Secondary | Overall survival (OS) | within the first 60 month after surgery |