Studieoverzicht - 2020-01 DESTINY-Br06

 
Number 2020-01 DESTINY-Br06
Nickname DESTINY-Br06
Status Submitted (METC) Date: 27-10-2020
Inclusion closed
Other study number(s) D9670C00001
Participating parties/groups AstraZeneca
Full title Phase III Study of DS-8201 versus Investigator’s Choice Chemotherapy in HER2-Low, Hormone Receptor Positive, Breast Cancer Patients who have Progressed on Endocrine Therapy in the Unresectable or Metastatic Setting
Phase and type Randomized Phase III
Age ≥ 18
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2- HR+
Target sample size 850
Actual accrual 0 Date: 27-10-2020
Estimated study completion date 01-10-2022
CCMO approval Date: 27-10-2020 Nr:
EudraCT nr.
Trial Register
METC approval Date: 27-10-2020 METC: Nr:
Amendments Date: 27-10-2020
KWF-CKS approval Date: 27-10-2020 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:

In this study, DS-8201 is being evaluated in a primary patient population of HER2-low (IHC 2+/ISH-, IHC 1+), HR-positive breast cancer who have progressed on endocrine therapy in the unresectable or metastatic setting. DS-8201 will also be evaluated in a HER2 > 0 population as well as a part of a secondary ITT population.

Objectives:

PRIMARY STUDY OBJECTIVES:

To assess the efficacy of DS-8201 compared with investigator’s choice chemotherapy in terms of PFS  for patients with HER2 IHC 1+/2+ expression.

SECONDARY STUDY OBJECTIVES:

·         Key secondary – To assess the efficacy of DS-8201 compared with investigator’s choice chemotherapy in terms of OS for patients with HER2 IHC 1+/2+ expression

·         Key secondary – To assess the efficacy of DS-8201 compared with investigator’s choice chemotherapy in terms of PFS and OS in the intent to treat population (HER2 IHC >0 and HER2 IHC 1+/2+)

·         To further assess the efficacy of DS-8201 compared with investigator’s choice chemotherapy in terms of ORR, and DoR for patients with HER2 IHC 1+/2+

·         To further assess the efficacy of DS-8201 compared with investigator’s choice chemotherapy in terms of ORR and DoR in the intent to treat population

·         To assess the efficacy of DS-8201 compared with investigator’s choice chemotherapy in terms of PFS according to investigator assessment for patients with HER2 IHC 1+/+

·         To assess the efficacy of DS-8201 compared with investigator’s choice chemotherapy in terms of ORR, DoR, and PFS according to investigator assessment and OS for patients with HER2 IHC >0

·         To assess the safety and tolerability profile of DS-8201 compared with investigator’s choice chemotherapy

·         To assess the PK of DS-8201

·         To assess symptoms, functioning  and HRQoL in patients with breast cancer treated with DS-8201 compared with investigator’s choice single agent chemotherapy

 

EXPLORATORY STUDY OBJECTIVES

·         To collect blood and tissue samples for defining biological responses to DS-8201 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:

Treatment with DS-8201 in patients with HER2-low, HR+ breast cancer who have progressed on ET in the unresectable or metastatic setting will derive a benefit in PFS and OS when compared with investigator’s choice chemotherapy.

Main eligibility criteria:

HER2-low, HR+ breast cancer patients who have progressed on ET in the unresectable or metastatic setting.

Patients must be  ≥18 years of age, RECIST v1.1 evaluable, and a World Health Organization/Eastern Cooperative Oncology Group performance status of 0 or 1 at enrollment.   

 

Documents (public):

Protocol synopsis

Documents (protected):
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