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Closed (no longer recruiting)Last updated: 3 January 2024

DB-08: 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 cancerA 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)

Clinical summary

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).

Conditions

This trial is treating patients with breast cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

I

Trial Acronym

DB-08

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

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)

Eligibility

Inclusion

  • Patients must be at least 18 years of age

  • Male or female patients who have pathologically documented breast cancer that:

    1. Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay
    2. Is documented as HR+ (either ER and/or PgR positive [ER or PgR ≥1%]) or ER and PgR negative (ER and PgR <1%) per ASCO/CAP guidelines in the metastatic setting
  • Patient must have adequate tumor sample for biomarker assessment
  • ECOG Performance Status of 0 or 1

For patients with HR+ disease:

Part 1: At least 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors), and at least 1 prior line of chemotherapy for MBC are required.

Part 2: Only 1 prior treatment line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) for MBC is allowed. No prior chemotherapy in the metastatic setting is allowed. Note there are no patients with HR+ disease in Part 2 of Modules 2 and 3.

For patients with HR- disease:

Part 1: At least 1 prior line of chemotherapy for MBC is required. Note there are no patients with HR- disease in Part 1 of Modules 4 and 5.

Part 2: For Module 2, no prior lines of therapy for MBC are allowed, and for Modules 1 and 3, only 1 prior line of chemotherapy for MBC is allowed. Note there are no patients with HR- disease in Part 2 of Modules 4 and 5.

Exclusion

  • Uncontrolled intercurrent illness
  • Uncontrolled or siginificant cardiovascular disease
  • History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Lung-specific intercurrent clinically significant illnesses
  • Has spinal cord compression or clinically active central nervous system metastases
  • Active primary immunodeficiency
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Prior treatment with ADC that comprises of an exatecan derivative that is a topoisomerase I inhibitor.

Inclusion

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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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