Clinical trial · Interventional
Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa
A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers. The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Doxorubicin-Cyclophosphamide
- description
- Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
- interventionNames
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin
- description
- Cisplatin q 3 wk x 4
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Rate of Pathologic Complete Response (pCR)
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic confirmation of invasive breast cancer * Stage: Clinical T1 \>/= 1.0 cm, T2 or T3, N0-3, M0 * HER2 negative * ER and PgR status by immunohistochemistry must be known. ER positive patients are allowed if physicain has determined neoadjuvant chemo is appropriate. * Life expectancy greater than six months * Use of an effective means of contraception is required Exclusion Criteria: * Pregnant or breastfeeding * Prior anthracycline or platinum based therapy * Prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy * Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for DCIS or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer * Peripheral neuropathy of any etiology that exceeds grade 1 * Significant hearing loss * Renal dysfunction * Use of other investigational or study agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs * Uncontrolled intercurrent illness * Any condition that would prohibit administration of corticosteroids * Uncontrolled diabetes * Pre-existing medical condition that would represent toxicity in excess of grade 1 as measured by CTCAE (unless not considered medically significant by the physician) * Known HIV positive individuals on combination antiretroviral therapy
References
Publications (3)
- DERIVEDTakamizawa S, Ishiki H, Shimoi T, Shimizu M, Satomi E. Neoadjuvant Cisplatin in BRCA Carriers With HER2-Negative Breast Cancer. J Clin Oncol. 2020 Aug 10;38(23):2699-2700. doi: 10.1200/JCO.20.00789. Epub 2020 Jun 9. No abstract available. PMID 32516091
- DERIVEDTung N, Hacker MR, Garber JE. Reply to S. Takamizawa et al. J Clin Oncol. 2020 Aug 10;38(23):2700-2701. doi: 10.1200/JCO.20.01190. Epub 2020 Jun 9. No abstract available. PMID 32516090
- DERIVEDTung N, Arun B, Hacker MR, Hofstatter E, Toppmeyer DL, Isakoff SJ, Borges V, Legare RD, Isaacs C, Wolff AC, Marcom PK, Mayer EL, Lange PB, Goss AJ, Jenkins C, Krop IE, Winer EP, Schnitt SJ, Garber JE. TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial). J Clin Oncol. 2020 May 10;38(14):1539-1548. doi: 10.1200/JCO.19.03292. Epub 2020 Feb 25. PMID 32097092