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 | 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 | 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:
|
|
Exploratory study objectives:
|
Progression Free Survival (PFS) - in HR+, HER2-low populaton
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.
Deelnemende centra:
NKI-AvL
Erasmus MC
Zuyderland MC
Amphia ziekenhuis
MC Leeuwarden
Ziekenhuisgroep Twente
Back