Studieoverzicht - 2020-01 DESTINY-Breast 06

Number 2020-01 DESTINY-Breast 06
Nickname DB-06
Status Active, not recruiting Date: 22-12-2022
Inclusion closed 22-12-2022
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 Any HER2, HR+
Target sample size 850 (wereldwijd)
Actual accrual NL: 13; Wereldwijd: 834 Date: 22-12-2022
Estimated study completion date 30-10-2025
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 , voor patienten:
Sponsor AstraZeneca
Principal Investigator(s)
Study manager AstraZeneca
Central datamanagement and randomization AstraZeneca
Monitoring AstraZeneca
Local datamanagement
Funding AstraZeneca
Extra De screening voor alle subgroepen is gesloten



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


Op 22Dec'22 is de IHC >0 <1+ subgroup gesloten voor screening.

Op15Dec'22 is de IHC2+ subgroep gesloten voor screening. 

Op 28Oct'22 is de IHC1+ subgroep gesloten voor recruitment.





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


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 by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)

  3. has HER2-low or HER2 IHC >0 <1+ expression as determined by central HER2 laboratory 

      result established on a tissue sample taken in the metastatic setting

  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:


Erasmus MC

Zuyderland MC

Amphia ziekenhuis 

MC Leeuwarden 

Ziekenhuisgroep Twente

Documents (protected):
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