Actively Recruiting
Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2024-03-29
152
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC. The first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0). The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd. The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months.
CONDITIONS
Official Title
Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have progressed during or within 2 months after treatment with T-DXd
- Patients with HER2-positive tumors must have prior treatment with trastuzumab and taxanes
- Patients with HER2-low tumors must have been treated with taxanes
- Patients with hormone receptor-positive tumors must have received endocrine therapy and CDK4/6 inhibitors
- Patients with germline BRCA1/2 mutations must have received prior PARP inhibitor treatment
- Adults aged 18 years or older
- Histologically confirmed advanced or metastatic breast cancer not suitable for surgery
- ECOG performance status of 0 or 1 at screening
- HER2-positive or HER2-low tumors with any hormone receptor status before T-DXd treatment
- At least one measurable lesion by RECIST v1.1 criteria or evaluable bone lesion with soft tissue component
- Tumor site accessible for biopsy and patient agrees to biopsies before, during, and after treatment
- Adequate bone marrow and organ function within 14 days before starting treatment
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception
- Female patients must not donate or retrieve eggs during and for 8 months after treatment
- Male patients must be surgically sterile or agree to use effective birth control during and for 5 months after treatment
- Male patients must not donate or freeze sperm during and for 5 months after treatment
- Ability and willingness to comply with study procedures and visits
- Affiliation with a social security system or beneficiary status
You will not qualify if you...
- Breast cancer that can be treated with surgery or radiation with curative intent
- History or evidence of interstitial lung disease or pulmonary fibrosis
- Severe lung problems or autoimmune diseases affecting the lungs
- Use of systemic corticosteroids over 10 mg/day prednisone or immunosuppressive therapy before treatment
- Evidence of leptomeningeal disease
- Clinically significant corneal disease
- Severe or uncontrolled systemic diseases or psychiatric illness affecting safety or compliance
- Active and symptomatic brain or spinal cord metastases requiring corticosteroids or anticonvulsants
- Inadequate washout periods from prior treatments including radiation, chemotherapy, immunotherapy, or surgery
- Prior treatment with anti-HER3 antibodies
- Unresolved toxicities from previous cancer therapies above grade 1 except certain stable chronic conditions
- Known allergies to HER3-DXd, T-DXd, monoclonal antibodies, or PARP inhibitors
- Other malignancies within 3 years except certain treated skin or in-situ cancers
- Significant uncontrolled heart conditions or abnormal heart tests
- Active hepatitis B or C infection not controlled or resolved
- Pregnant or breastfeeding women
- HIV infection not well controlled or unstable
- Medical or psychiatric conditions that could affect safety or study results
- Legal incapacity or inability to consent
- Participation in another experimental drug trial within 4 weeks
- For module 1, history of hypersensitivity to olaparib or inadequate washout of CYP3A inhibitors or inducers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gustave Roussy Institut
Villejuif, France, 94805
Actively Recruiting
Research Team
B
Barbara Pistilli
CONTACT
F
Fernanda Mosele
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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