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 Daiichi - 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 (wereldwijd)
Actual accrual NL: 2; Wereldwijd: 225 Date: 18-11-2021
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 https://www.destinyclinicaltrials.com/ , voor patienten: https://www.kanker.nl/trials/1217
Sponsor AstraZeneca
Principal Investigator(s)
Study manager AstraZeneca
Central datamanagement and randomization AstraZeneca
Monitoring AstraZeneca
Local datamanagement
Funding AstraZeneca
Extra Patients who are HER2 IHC0 according to local pathology may also be informed and have the pre-screen ICF drawn to determine the Her2 status. Of this group IHC0, a significant part appears to fall within the very low Her2 expression group (IHC>0 <1+) at the central level and may still participate.

Design:

 

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy.

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.

  6. No prior chemotherapy for advanced or metastatic breast cancer.

  7. Has adequate tumor samples for assessment of HER2 status

  8. Must have either:

   a. disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or;

   b. disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting (progression

       of disease within 24 months on adjuvant ET is considered a line of therapy)

  9. 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

 

 

Deelnemende centra:

NKI-AvL (open)

Erasmus MC (open)

Zuyderland MC (open)

Amphia ziekenhuis (open)

MC Leeuwarden (open)

Ziekenhuisgroep Twente (initiating) 

Documents (protected):
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