Trastuzumab Deruxtecan (T-DXd) for Subjects with Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC0 Breast Cancer (BC)
- Conditions
- nresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast CancerMedDRA version: 23.0Level: PTClassification code: 10083232Term: HER2 negative breast cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505616-38-00
- Lead Sponsor
- Daiichi Sankyo Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 268
Subject must sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures., Has a left ventricular ejection fraction (LVEF) = 50% within 28 days before enrolment., Has adequate organ and bone marrow function within 28 days before enrollment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to Screening assessment. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 3 days of enrollment as appropriate. Adequate organ/bone marrow function are defined in the protocol., Has adequate treatment washout period before enrollment, as defined in protocol., Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Methods considered as highly effective methods of contraception are described in the protocol., Male subjects must not freeze or donate sperm starting at enrollment and throughout the study period and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study., Female subjects must not donate, or retrieve for their own use, ova from the time of enrollment, throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study., Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions., Adults =18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed., Must agree to provide a newly obtained or archival baseline biopsy from primary and/or metastatic lesion. All participants must provide a formalin-fixed paraffin-embedded (FFPE) tumour sample that meets the tissue requirements for tissue-based analysis (including but not restricted/limited to IHC staining to determine HER2 expression, ISH staining when necessary for HER2-low status, and other predictive biomarkers as well as tumour mutational analysis). A newly acquired sample from a fresh biopsy will be used if available; however, submission of the subject’s most recent biopsy prior to the date of Screening and after the subjects’ last treatment regimen as per ASCO CAP guidelines is permitted for testing in a local laboratory. This archival sample must have been obtained within 6 weeks before Tissue Screening. If a previously collected sample does not have sufficient material for a minimum of 15 × 4-micron sections (or block equivalent), a fresh biopsy must be collected., Pathologically documented BC tumour that: a. Is unresectable and/or metastatic. b. Is hormone receptor-negative or hormone receptor-positive. c. Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC0 status as determined according to ASCO CAP 2018 HER2 testing guidelines based on sample collected during Tissue Screening as described above in Inclusion Criterion No. 3. d. Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per ASCO CAP guidelines). e. Was never previously treated with anti-HER2 therapy
Prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (other than sacituzumab govitecan) including prior participation in a study involving an ADC produced by Daiichi Sankyo and/or AstraZeneca., Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Subjects should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)/ethics committee (EC). Subjects with past or resolved hepatitis B virus (HBV) infection are eligible only if they meet all criteria described in the protocol., Has history of receiving a live, attenuated vaccine (messenger RNA [mRNA] and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study drug., Has unresolved toxicities from previous anti cancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade =1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to >Grade 2 for at least 3 months prior to enrollment and managed with standard of care treatment) that the investigator deems related to previous anti cancer therapy including the following: a. Chemotherapy-induced neuropathy b. Fatigue c. Residual toxicities from prior immune-oncology (IO) treatment: Grade 1 or Grade 2 endocrinopathies, which may include the following: Hypothyroidism/hyperthyroidism; Type 1 diabetes; Hyperglycemia; Adrenal insufficiency; Adrenalitis; Skin hypopigmentation (vitiligo), Is pregnant or breastfeeding or planning to become pregnant., Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc)., Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis, Sjogren’s, sarcoidosis, etc) where there is documented or a suspicion of pulmonary involvement at the time of Screening. Full details of the disorder should be recorded in the electronic case report form (eCRF) for subjects who are included in the study., Prior complete pneumonectomy., As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including ongoing or active infection, uncontrolled hypertension, renal transplant, active bleeding diseases, or serious chronic gastrointestinal conditions associated with diarrhea) substantially increasing risk of incurring AEs, which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or would jeopardize compliance with the protocol., Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject’s participation in the clinical study or evaluation of the clinical study results., Social, familial, or geographical factors that would interfere with study participation or follow-up., Uncontrolled or significant cardiovascular disease including any of the following: a. Sub
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