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

  • STATUS
    Recruiting
  • End date
    Aug 28, 2023
  • participants needed
    185
  • sponsor
    AstraZeneca
Updated on 21 April 2021

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

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

Details
Condition Metastatic Breast Cancer, Stage IV Breast Cancer
Treatment Capecitabine, Paclitaxel, durvalumab, anastrozole, fulvestrant, Capivasertib, Trastuzumab deruxtecan
Clinical Study IdentifierNCT04556773
SponsorAstraZeneca
Last Modified on21 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Stage IV Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Stage IV Breast Cancer?
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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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