Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT06508216
Status:
RECRUITING
Last Update Posted:
2024-07-22
First Post:
2024-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Organization:
Study Overview
Official Title:
A Phase Ib/II, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPASS-TNBC
Brief Summary:
Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer:
A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and anti-tumor activity of novel therapeutics in patients with early relapsed metastatic triple-negative breast cancer
A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and anti-tumor activity of novel therapeutics in patients with early relapsed metastatic triple-negative breast cancer
Detailed Description:
Every year, approximately 170.000 women are diagnosed with triple negative breast cancer (TNBC) and about 80-85% present with a stage II or III tumor making them eligible to neoadjuvant chemotherapy (NACT). Despite the substantial outcome improvements achieved with neoadjuvant chemotherapy-based strategies, at least 50-60% of patients with TNBC do not achieve pCR and are at higher risk of presenting with early disease recurrences. About 40% of patients with no-pCR experience distant recurrences within 12 months from the end of (neo)adjuvant treatments. Overall, 20-25% of patients with TNBC develop an early recurrence at ≤ 12 months from the end of (neo)adjuvant chemotherapy. Neither standard chemotherapy options nor approved targeted therapies exist for 35.000-40.000 women/year with TNBC (≈1200 women/year in France) that progress during (neo)adjuvant treatment or within 1 year from its termination. These patients present a "hard-to-treat" disease and a disproportionately high rate of morbidity and mortality. Notwithstanding, they are excluded from most current clinical trials that evaluate the efficacy of innovative strategies, with immunotherapy or targeting therapies in combination with chemotherapy. The treatment algorithm in 1st line is often based on the use of platine-containing regimens that provide very low response rates (less than 15%), no more than 2-3 months of 1st-line PFS and a median OS of about 9 months. Yet, comprehensive genomic analyses performed over the past years on patients with residual disease after neoadjuvant chemotherapy have not introduced concrete findings for guiding drug development in this setting. Comparisons of initial biopsies with post-NACT tumor tissues revealed a wide range of profound tumor changes acquired under the selective pressure of NACT that encompass the development of dominant subclones, tumor immune depletion and stem-cell phenotype enrichment that cannot be addressed with a single treatment strategy. Therefore, it is necessary to explore a broad range of treatment approaches to cover the different patterns involved. The idea is to set a rapidly recruiting phase I-II trials allowing to explore new treatment-strategies in patients with early recurrent and highly refractory TNBC have the potential to fulfil this utmost and urgent medical need.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022/3571 | OTHER | CSET number | View |