Actively Recruiting
Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC
Led by National Taiwan University Hospital · Updated on 2024-06-10
42
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label randomized phase II study in estrogen receptor positive locally advanced or metastatic breast cancer patients. The main inclusion population are either luminal subtype B by PAM50 analysis or failed less than 2 lines of hormonal therapy for locally advanced or metastatic breast cancer. The subjects have to be premenopausal or perimenopausal and are not allowed to receive any systemic chemotherapy for their locally advanced or metastatic breast cancer. Eligible subjects will be randomized into goserelin/ fulvestrant/ durvalumab (Arm A), goserelin/ fulvestrant/ capivasertib/ durvalumab (Arm B), or goserelin/ fulvestrant/ capivasertib (Arm C) at a 1:1:1 ratio. The primary endpoint is objective response rate (ORR) of the whole other three arm compared to historical goserelin/ fulvestrantcontrol arm. The major secondary endpoint will be progression-free survival or ORR compared among different treatment arms.
CONDITIONS
Official Title
Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed estrogen receptor positive invasive breast cancer (>1%)
- Locally advanced or metastatic disease with at least one measurable target lesion
- No prior chemotherapy for locally advanced or metastatic breast cancer
- Either primary resistance to hormonal therapy (recurrence within 2 years of adjuvant hormonal therapy) or resistant to prior hormonal therapy (failed 2 or fewer lines for advanced disease)
- Premenopausal or perimenopausal women confirmed by clinical history or hormone levels; premenopausal status before LHRH agonist use allowed if documented
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ and marrow function within 14 days before randomization
- Age older than 20 years
- Negative pregnancy test within 7 days before starting therapy; not breastfeeding
- Effective contraception for women of reproductive potential during and for 6 months after study
- Ability to comply with study procedures and provide written informed consent
- Body weight over 30 kg
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Prior treatment with capivasertib, fulvestrant, anti-PD1 or anti-PDL1 immunotherapy
- Prior chemotherapy for locally advanced or metastatic breast cancer
- Radiotherapy with wide field within 4 weeks before first study dose
- HER-2 positive tumor by IHC 3+ or IHC 2+/ISH positive
- Active brain metastases or spinal cord compression unless stable and asymptomatic without steroids for 4 weeks
- Other malignancies within 5 years except certain treated skin or cervical cancers
- Psychiatric or social conditions preventing study compliance
- Serious non-healing wound, ulcer, or bone fracture
- Major surgery or significant injury within 28 days before enrollment; minor surgery within 7 days
- Allergy to study drugs or similar compounds
- Pregnancy or breastfeeding
- Unresolved toxicities over grade 1 (except alopecia) from prior therapy
- Active infections including tuberculosis, hepatitis B or C without resolved status
- Known HIV positive status
- History of organ transplantation
- Active or prior autoimmune or inflammatory disorders except specified exceptions
- Uncontrolled illnesses including heart failure, hypertension, arrhythmia, lung or gastrointestinal diseases affecting absorption
- History of other primary malignancies with some exceptions
- History of leptomeningeal carcinomatosis
- Prior allogeneic bone marrow or solid organ transplant
- Recent immunosuppressive medication use except specified exceptions
- Live vaccines within 30 days before first study dose
- Cardiac abnormalities including QTc prolongation, arrhythmias, or recent serious cardiac events
- Significant glucose metabolism abnormalities including insulin-dependent diabetes or high HbA1c
- Use of certain drugs affecting metabolism within specific time frames
- Participation in other clinical trials with investigational drugs recently
- Hypersensitivity to study drugs or excipients
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
Y
Yen-Shen Lu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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