Studieoverzicht - 2020-01 DESTINY-Breast 06

 
Number 2020-01 DESTINY-Breast 06
Nickname DB-06
Status Open Date: 14-04-2021
Inclusion closed
Other study number(s) D9670C00001
Participating parties/groups AstraZeneca
Full title A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) versus Investigator’s Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Phase and type Randomized Phase III
Age ≥ 18
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2- HR+
Target sample size 850 (global)
Actual accrual 0 Date: 29-06-2021
Estimated study completion date 18-04-2025
CCMO approval Yes Date: 01-02-2021 Nr: NL73583.056.20
EudraCT nr. 2019-004493-26
Trial Register
METC approval Yes Date: METC: Nr:
Amendments Date:
KWF-CKS approval Date: Nr:
News item
Website
Sponsor AstraZeneca
Principal Investigator(s)
Study manager AstraZeneca
Central datamanagement and randomization AstraZeneca
Monitoring AstraZeneca
Local datamanagement
Funding AstraZeneca
Extra

Design:

 

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Objectives:

 

Primary study objectives:

To assess the efficacy of trastuzumab deruxtecan compared to chemotherapy on progression free survival (PFS) of the population

 

Secondary study objectives:

  • Assess the efficacy of trastuzumab deruxtecan compared to chemotherapy on overall survival (OS) of the population
  • Assess the efficacy of trastuzumab deruxtecan compared to chemotherapy on overall survival (OS) in the HER2 ICH>0<1 sub-group
  • Compare the 2 treatment arms in terms of ORR, DoRPFS2, TFST, TSST, HRQoL
  • Assess the safety of trastuzumab deruxtecan
  • Investigate the PK and immunogeneticity of trastuzumab deruxtecan

 

Exploratory study objectives:

  • To collect blood and tissue samples for defining biological responses to trastuzumab deruxtecan and identifying candidate markers that may correlate with likelihood of clinical benefit
  • To explore the impact of treatment and disease state on health utility using the EQ-5D-5L
  • To assess patient-reported treatment tolerability
  • To assess the patient’ overall impression of the severity of their cancer symptoms and change in condition since starting the study
  • To explore the impact of treatment and disease on health care resource use
  • To explore & optimize technologies for detection of HER2 protein expression
Endpoints:

 

Progression Free Survival (PFS) - in HR+, HER2-low populaton

Main eligibility criteria:

 

Key Inclusion Criteria:
• Patients must be ≥18 years of age.
• Pathologically documented breast cancer that:
1. is advanced or metastatic
2. has a history of HER2-low or negative expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC >0 <1+ (ISH- or untested)
3. has historical HER2-low or HER2 IHC >0 <1+ expression confirmed by central HER2 laboratory testing to have HER2-low expression or HER2 IHC >0 <1+ expression, respectively
4. was never previously HER2-positive
5. is documented HR+ disease in the metastatic setting.
• No prior chemotherapy for advanced or metastatic breast cancer.
• Has adequate tumor samples for assessment of HER2 status
• Disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy (Progression of disease within 24 months on adjuvant ET is considered a line of therapy)
• Has protocol-defined adequate organ and bone marrow function.

 

Key Exclusion Criteria:
• Ineligible for all options in the investigator’s choice chemotherapy arm
• Uncontrolled intercurrent illness or significant cardiovascular disease
• Active or prior documented ILD/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
• Lung-specific intercurrent clinically significant illnesses
• Patients with spinal cord compression or clinically central nervous system metastasis.

Documents (public):

 

Patiënt Poster

 

Patiënt Brochure

 

 

Documents (protected):
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