Breast Cancer Clinical Trial
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
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
Full Description
This study is modular in design allowing assessment of the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies. Combination-treatment modules 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 RP2D determined in Part 1.
The target population of interest in this study is patients with HER2-low (IHC 1+ or IHC 2+/ISH -) (as per ASCO/CAP 2018 guidelines) advanced/MBC. Part 1 of each module will enroll patients with locally confirmed HER2-low advanced/MBC in second-line or later (≥ 2L) settings
Part 2 of each module will enroll patients with HER2-low MBC who have either not received prior treatment, or received only 1 prior treatment (depending on the module-specific exclusion criteria) for advanced/metastatic disease
Eligibility Criteria
Key Inclusion Criteria:
Patients must be at least 18 years of age
Male or female patients who have pathologically documented breast cancer that:
Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 40 Locations for this study
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10029, United States
New York New York, 10065, United States
Uniondale New York, 11553, United States
Chapel Hill North Carolina, 27514, United States
Chattanooga Tennessee, 37404, United States
Germantown Tennessee, 38138, United States
Fort Worth Texas, 76104, United States
East Melbourne , 3002, Australia
Westmead , 2145, Australia
Edegem , 2650, Belgium
Leuven , 3000, Belgium
Ottignies , 1340, Belgium
Florianópolis , 88034, Brazil
Goiania , 74605, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90110, Brazil
Sao Paulo , 01317, Brazil
Sao Paulo , 04543, Brazil
São Paulo , 03102, Brazil
São Paulo , 04538, Brazil
Kelowna British Columbia, V1Y 5, Canada
Quebec , G1J 1, Canada
Villejuif Cedex , 94805, France
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Monterrey , 64710, Mexico
Moscow , 11547, Russian Federation
Moscow , 14344, Russian Federation
Saint Petersburg , 19922, Russian Federation
Kaohsiung , 82445, Taiwan
Taichung , 40443, Taiwan
Taipei City , 114, Taiwan
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
Taipei , 235, Taiwan
Taoyuan , 333, Taiwan
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.