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CB-103 Plus NSAI In Luminal Advanced Breast Cancer

NCT04714619 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-12-19

No results posted yet for this study

Summary

Multicenter, single-arm, open label, phase II clinical trial with safety run-in to evaluate the safety, tolerability, pharmacokinetics and efficacy of CB-103 in combination with a non-steroidal aromatase inhibitor (NSAI), anastrozole or letrozole, in Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer patients who have achieved clinical benefit during prior NSAI-based treatment.

Conditions

Interventions

DRUG

CB-103

Patients will receive CB-103 capsules orally (QD) in combination with NSAI therapy (letrozole or anastrozole, continuing prior therapy) also orally once daily, and based on a 28-day treatment cycle. A run-in phase for safety and tolerability of CB-103 in combination with anastrozole or letrozole will be conducted as an initial step of the phase II trial to confirm the safe dose of CB-103 in combination with NSAI given at standard dose. Patients will receive treatment until disease progression (as defined by RECIST v.1.1), symptomatic deterioration, unacceptable toxicity, death, consent withdrawal or study termination, whichever occurs first.

Sponsors & Collaborators

  • Cellestia Biotech AG

    collaborator INDUSTRY

  • MedSIR

    lead OTHER

Principal Investigators

  • Antonio Llombart-Cussac · Arnau de Vilanova Hospital, Valencia (Spain)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2021-09-02
Completion
2022-04-26

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714619 on ClinicalTrials.gov