Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508216
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
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:
None
Organization:
None
Study Overview
Official Title:
A Phase IbII 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:
No
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 IbII 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 IbII 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 170000 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 neoadjuvant treatments Overall 20-25 of patients with TNBC develop an early recurrence at 12 months from the end of neoadjuvant chemotherapy Neither standard chemotherapy options nor approved targeted therapies exist for 35000-40000 womenyear with TNBC 1200 womenyear in France that progress during neoadjuvant 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None