A proof of concept study to evaluate treatments´efficacy by monitoring Minimal Residual Disease using ctDNA in HR-positive/HER2-negative early breast cancer populatio
- Conditions
- Early-stage, Hormone Receptor (HR)-positive / Human Epidermal Growth Factor Receptor 2 (HER2)-negative, breast cancer (BC)Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505661-89-00
- Lead Sponsor
- Medica Scientia Innovation Research S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1260
Only for surveillance phase: Signed informed consent form (ICF) prior to participation in any study-related activities, Only for surveillance phase: Absence of metastatic disease by routine clinical assessment (computed tomography [CT] scan of the thorax and abdomen, and bone scan) confirmed no longer than three months prior to study inclusion, Only for surveillance phase: Patients must have had surgery for their primary BC with documented clear margins (as per local guidelines) within the past five years, Only for surveillance phase: Patients must be able and willing to adhere to study procedures, Only for treatment phase: Signed ICF prior to study inclusion., Only for treatment phase: ctDNA positivity with no evidence of clinical or radiologic recurrence by standard assessments (e.g.: breast ultrasound, staging scans, RMN)., Only for treatment phase: ECOG performance status 0, 1 or 2., Only for treatment phase: Patients must have received the same ET during at least the last 12 months. A temporary discontinuation of < 90 days during the surveillance phase is allowed., Only for treatment phase: Receiving LHRH agonist therapy alongside the same ET treatment for at least 90 days prior to initiation of one of the available study treatments if male or pre-menopausal., Only for treatment phase: Female of reproductive potential and male patients with female partners of childbearing potential, must remain abstinent and truly abstain from sexual activity (refrains from heterosexual intercourse) or use locally recognized adequate methods of contraception (described as that with a failure rate <1%) for the duration of trial treatment. In addition, patients must follow these guidelines for a certain period of time after the last dose of trial treatment, specified in the protocol (Section 7.4.4) depending on which treatment arm the patient is allocated in. During this indicated period of time, female and male patients must as well refrain from donating eggs or sperm. Note: Female patients will be deemed not of childbearing potential if they are post-menopausal or have had irreversible sterilization. Well-defined pre-menopausal status refers to women who have not reached the post-menopausal state because they are not permanently infertile due to prior bilateral oophorectomy, age =60 years or age <60 years with amenorrhea for =12 months and estradiol and follicle-stimulating hormone (FSH) levels in the postmenopausal range., Only for treatment phase: Resolution of all acute toxic effects of prior anti-cancer therapy to Grade =1 as determined by the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0 (except for alopecia, or other toxicities not considered a safety risk for the patient at investigator's discretion). Adverse events (AEs) of current ET treatment are not included., Only for surveillance phase: Male or female patients aged 18 years or older, Only for treatment phase: Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1, defined by the following: • Hematological (without platelet, red blood cell (RBC) transfusion, and/or granulocyte colony-stimulating factor support within 7 days before first study treatment dose): White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) = 1.5 x 109/L, platelet count = 100.0 x109/L, and hemoglobin = 9.0 g/dL (= 5.6 mmol/L). • Hepatic: Serum albumin = 3 g/dL; Bilirubin = 1.5 times th
Any concurrent or planned treatment for the current diagnosis of BC other than adjuvant ET, Participants with renal dysfunction who require dialysis, Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’ opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol, Females who are known to be breastfeeding or pregnant as determined by a serum pregnancy test, Human chorionic gonadotropin (ß-HCG), prior to the administration of any trial treatment. Since ß-HCG over expression can be also elevated in some tumor types, a positive result should be confirmed with a validated alternative test (e.g., ultrasound)., Female or male participants planning a pregnancy, Only for treatment phase: Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances, Only for treatment phase: Undergoing any other simultaneous anti-cancer treatment since enrolling in the study, other than hormonal therapy or a bisphosphonate (or denosumab)., Only for treatment phase: Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 28 days of start of study drug, or patients who have not recovered from the side effects of any major surgery., Only for treatment phase: Treatment with strong Cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 14 days or five drugelimination half-lives, whichever is longer, prior to initiation of one of the available study treatments, Only for treatment phase: Patient has a history of non-compliance to medical regimen, Only for treatment phase, Arm D: Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes, Diagnosis of an alternative cancer in the five years prior to primary BC diagnosis other than for non-melanoma carcinoma of the skin or cervical carcinoma in situ. Other stage I tumors will be discussed case by case prior to inclusion with the Medical Monitor of the study, Only for treatment phase, Arm D: Fasting glucose =126 mg/dL or =7.0 mmol/L and hemoglobin A1C (HbA1c) = 6.0%., Only for treatment phase, Arm D: Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition., Only for treatment phase, Arm D: Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye., Only for treatment phase, Arm D: Inability to confirm biomarker eligibility based on valid results from either central testing of blood or local testing of blood or tumor tissue that documents one of the protocol-defined PIK3CA mutations., Active or prior documented inflammatory bowel disease (i.e. Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in baseline grade =1 diarrhea) that may significantly alter the absorption of oral drugs, Active cardiac disease or history of cardiac dysfunction including any of the following: a. History (within two years from screening) or presence of idiopathic bradycardia or resting heart rate <50 beats per minute at screening. b. History of angina pectoris or symptomatic coronary heart disease within 12 months prior to study entry. c. QT interval corrected through use of F
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