DB-08 : A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase I study is trying to understand how safe and tolerable a targeted cancer drug (trastuzumab deruxtecan) is in combination with other anti-cancer drugs in people with metastatic breast cancer.
 

This trial is treating patients with breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

Commercial Sponsor

AstraZeneca

Summary

This is a non-randomised study initially consisting of 5 treatment modules, each of which includes T-DXd (Trastuzumab deruxtecan) in combination with other anti-cancer agents. Each module will have 2 parts: a dose-finding phase (Part 1) and a dose-expansion phase (Part 2). The Part 2 dose-expansion phase will use the recommended Phase 2 dose (RP2D) for the combination, either as determined in Part 1 or from another clinical study if appropriate. For each module, patients will be centrally assigned to one of the open modules, as per the module specific criteria. In Module 1, participants will receive T-DXd (administered intravenously, 5.4 mg/kg Q3W) in combination with Capecitabine (administered orally, 100mg/m2 BID, days 1-14 Q3W). In Module 2, participants will receive T-DXd (administered orally, 5.4 mg/kg Q3W) in combination with Durvalumab (administered intravenously, 1120mg Q3W) and paclitaxel (administered intravenously, 90mg/m2 QW in 3-week cycles). In Module 3, participants will receive T-DXd (administered intravenously, 5.4mg/kg Q3W) in combination with capivasertib (administered orally, 400mg BID). In Module 4, participants will receive T-DXd (administered intravenously, 5.4mg/kg Q3W) in combination with Anastrozole (administered orally, 1mg daily). In Module 5, participants will receive T-DXd (administered intravenously, 5.4mg/kg Q3W) in combination with Fulvestrant (administered as an intramuscular injection, 500mg Q4W).

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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