Study Summary
This trial is a Phase II study of cisplatin in patients with BRCA-mutated breast cancer.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 5 years
2 years
Number of Grade 3 and Grade 4 Adverse Events
Rate of Residual Cancer Burden (RCB) 0/1
3 years
Clinical Response Rate
Rate of Miller Payne 4 and 5
Rate of Pathologic Complete Response (pCR)
5 years
Analysis of Pre-chemotherapy Biopsies
Rate of Recurrence Free Survival (RFS) After Cisplatin or AC
Rate of Recurrence Free Survival (RFS) With Pathologic Complete Response (pCR) vs. With no pCR
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Cisplatin
1 of 2
Doxorubicin-Cyclophosphamide
1 of 2
Active Control
118 Total Participants · 2 Treatment Groups
Primary Treatment: Cisplatin · No Placebo Group · Phase 2
Cisplatin
Drug
ActiveComparator Group · 1 Intervention: Cisplatin · Intervention Types: DrugDoxorubicin-CyclophosphamideActiveComparator Group · 2 Interventions: Cyclophosphamide, Doxorubicin · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
777 Previous Clinical Trials
845,636 Total Patients Enrolled
43 Trials studying Breast Cancer
5,303 Patients Enrolled for Breast Cancer
Nadine Tung, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
2 Previous Clinical Trials
414 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The patient has Stage Clinical T1 >/= 1.0 cm, T2 or T3, N0-3, M0.
The patient is likely to live for more than six months.
Patients who are ER and PgR positive by immunohistochemistry must have their status known
References
- Takamizawa, Shigemasa, Hiroto Ishiki, Tatsunori Shimoi, Masaki Shimizu, and Eriko Satomi. 2020. “Neoadjuvant Cisplatin in brca Carriers with Her2‐negative Breast Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.00789.
- Tung, Nadine, Michele R. Hacker, and Judy E. Garber. 2020. “Reply to S. Takamizawa Et Al”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.01190.
- Tung, Nadine, Banu Arun, Michele R. Hacker, Erin Hofstatter, Deborah L. Toppmeyer, Steven J. Isakoff, Virginia Borges, et al.. 2020. “TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-cyclophosphamide in Germline brca Carriers with Her2-negative Breast Cancer (the INFORM Trial)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.03292.
- Takamizawa 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.
- Tung 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.
- Nadine Tung, MD 2012. "Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01670500.
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Conditions
Cancer Related
Treatments