Study of Trastuzumab Deruxtecan (DS-8201a, 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
- Conditions
- HER2-Low, Hormone Receptor Positive Breast Cancer which has Progressed on Endocrine Therapy in the Metastatic Setting.MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-004493-26-DE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 850
Key Inclusion Criteria:
• Patients must be =18 years of age.
• Pathologically documented breast cancer that:
a. is advanced or metastatic
b. 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)
c. has HER2-low or HER2 IHC >0 <1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic disease setting
d. was never previously HER2-positive
e. has documented HR+ disease in the metastatic disease setting.
• 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) or disease progression on endocrine therapy + CDK4/6 inhibitor within 6 months of starting first line treatment for metastatic disease and considered appropriate for chemotherapy as the next treatment by the investigator.
• No prior chemotherapy for advanced or metastatic breast cancer.
• Has protocol-defined adequate organ and bone marrow function. The most recent results must be used to meet this inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 765
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
KKey Exclusion Criteria:
• Ineligible for all options in the investigator's choice chemotherapy arm. Patients with contraindications to capecitabine, paclitaxel, and nabpaclitaxel treatment, per local prescribing information, cannot be enrolled
• Uncontrolled intercurrent illness or significant cardiovascular disease
• Active or prior documented ILD/pneumonitis that required steroids 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 active clinically central nervous system metastasis.
•Concurrent enrolment in another clinical study, unless it is
_ an observational (non-interventional) clinical study
_ during the follow up period of a prior interventional study (pre-screening for this study while a patient is on treatment in another clinical study is acceptable)
•Have received a study treatment from a prior interventional study, administered in the last 30 days prior to first dose of this study treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method