FULVESTRANT for Advanced breast cancer | Hormone receptor-positive, HER2-negative advanced breast cancer

Inclusion criteria

• {"criterion_text":"- 1.\tAge ≥ 18 years\n- 10.\tPatient must have normal organ and marrow function\n- 11.\tAdequate renal function\n- 12.\tFemale participant must have a negative serum pregnancy test.\n- 13.\tUse of contraceptive if applicable\n- 14.\tMeasurable disease, i.e., at least one measurable lesion as per RECIST 1.1.\n- 15.\t. Patient affiliated to regimen of social security\n- 16.\tAre capable of giving signed informed consent (or a trusted person).\n- 2.\tMan or postmenopausal woman due to either surgical/natural menopause or chemical ovarian suppression.\n- 3.\tPatient has advanced breast cancer\n- 4.\tPatient has pathologically confirmed hormone receptors (HR)-positive and HER2-negative advanced BC. HER2- negative breast\n- 5.\tPatient has disease progression while receiving aromatase inhibitor therapy in combination with CDK4/6 inhibitors\n- 6.\tNo more than one previous chemotherapy regimen for advanced disease.\n- 7.\tNo more than 1 previous endocrine therapy administered for metastatic disease.\n- 8.\tPatient with gBRCA1/2 must have received PARP inhibitors and have experienced disease progression during or after treatment\n- 9.\tECOG Performance Status of 0 or 1."}

Exclusion criteria

• {"criterion_text":"- Has received previous fulvestrant\n- Concomitant use of known strong or moderate CYP3A inducers\n- Persistent toxicities (≥ CTCAE grade 2) caused by previous cancer therapy\n- Major surgery within 2 weeks of starting study treatment or an anticipated need for major surgery during the study...\n- Visceral crisis or impending visceral crisis at time of screening.\n- HIV, HBV or HCV infection\n- Any other clinical condition, uncontrolled concurrent illness, or other situations, which in the Investigator’s opinion would not make the patient a good candidate for the study or may potentially impact the absorption of M1774\n- Live vaccines within 4 weeks of first dose of study intervention and while receiving study intervention.\n- Patients unable to swallow orally administered medication\n- History or known hypersensitivity to the active substances or to any excipients of the study interventions.\n- Pregnant or breast feeding women.\n- Any investigational therapy within ≤ 21 days or 5 half-lives prior treatment, whichever is longer, prior treatment\n- Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up\n- Any hormonal therapy within 7 days prior treatment (except ovarian function suppression)\n- Any cytotoxic therapy within 21 days (3-weekly regimen), 14 days (weekly or oral regimen) prior treatment.\n- Previous treatment with ATR or CHK1 inhibitors. Prior treatment with PARP inhibitor is allowed.\n- Patients with second primary cancer\n- Mean resting corrected QTc interval using the Fridericia formula\n- Cardiac or vascular diseases currently or within the last 6 months\n- Concomitant use of known strong cytochrome P (CYP) 3A inhibitors or moderate CYP3A inhibitors."}

Primary endpoints

• {"endpoint_text":"- incidence of dose-limiting toxicity","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Tolerance: incidence of AEs and Serious Adverse Events (SAE) presented by grade according to the NCI-CTCAE v5.0.","definition_or_measurement_approach":"Presented by grade according to the NCI-CTCAE v5.0."}
• {"endpoint_text":"- overall response rate (ORR) as defined as the percent of patients with a complete response (CR) or a partial response (PR) (RECIST v1.1).","definition_or_measurement_approach":"ORR defined as percent of patients with CR or PR per RECIST v1.1."}
• {"endpoint_text":"- The progression-free survival (PFS) as defined as the interval between the date of inclusion and the date of progression or death. A patient alive and without progression will be censored at the last date of follow-up.","definition_or_measurement_approach":"PFS = time from inclusion to progression or death; patients alive without progression censored at last follow-up."}
• {"endpoint_text":"- PK evaluation will be performed on typical individual pharmacokinetics parameters (","definition_or_measurement_approach":"PK evaluation on typical individual pharmacokinetic parameters (detailed parameters not provided / truncated in source)."}

France

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

07-10-2025

Processing Time Days

621

Number Of Sites

12

Number Of Participants

57

Primary sponsor

Full Name

Institut Paoli-Calmettes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Institut National du Cancer","duties_or_roles":"Source of monetary support","organisation_type":""}