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Clinical Trials in the USA / NCT04556773
Active, not recruiting Phase 1

A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

NCT04556773 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 1
Started
2020-12-17
Last updated
2026-08-03

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

Trastuzumab deruxtecan →Durvalumab →Paclitaxel →Capivasertib →Anastrozole →Fulvestrant →Capecitabine →

Trastuzumab deruxtecan: T-DXd: administered as an IV infusion

Durvalumab: Durvalumab: administered as an IV infusion

Paclitaxel: Paclitaxel: administered as an IV infusion

Capivasertib: Capivasertib: administered orally

Anastrozole: Anastrozole: administered orally

Fulvestrant: Fulvestrant: administered as an IM injection

Capecitabine: Capecitabine: administered orally

Study summary

DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Research Site Commack New York
Research Site Harrison New York
Research Site New York New York
Research Site New York New York
Research Site Uniondale New York
Research Site Chapel Hill North Carolina
Research Site Chattanooga Tennessee
Research Site Germantown Tennessee
Research Site Fort Worth Texas
Research Site Melbourne Australia
Research Site Westmead Australia
Research Site Edegem Belgium
Research Site Leuven Belgium
Research Site Ottignies Belgium
Research Site Goiânia Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Kelowna British Columbia
Research Site Québec Quebec
Research Site Villejuif France
Research Site Monterrey Mexico
Research Site Moscow Russia
Research Site Moscow Russia
Research Site Saint Petersburg Russia
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Kaohsiung City Taiwan
Research Site Taichung Taiwan
Research Site Taipei Taiwan
Research Site Taipei Taiwan
Research Site Taipei Taiwan
Research Site Taipei Taiwan
Research Site Taoyuan Taiwan

On this site

📄 Enhertu (trastuzumab deruxtecan) drug profile → 📄 Imfinzi (durvalumab) drug profile →

More AstraZeneca trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04556773 on ClinicalTrials.gov ↗ ← All trials in the USA