A Phase II study of post-operative palbociclib as an alternative to chemotherapy in older patients with localized breast cancer at high risk of relapse

Phase 1

• Conditions: ocalized ER+ breast cancer; MedDRA version: 23.0Level: LLTClassification code: 10070577Term: Oestrogen receptor positive breast cancer Class: 10029104; MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2; MedDRA version: 20.0Level: HLGTClassification code: 10006291Term: Breast neoplasms malignant and unspecified (incl nipple) Class: 10029104; MedDRA version: 20.0Level: HLTClassification code: 10006290Term: Breast and nipple neoplasms malignant Class: 10029104; MedDRA version: 23.0Level: LLTClassification code: 10070575Term: Estrogen receptor positive breast cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-505223-31-00
• Lead Sponsor: European Organisation For Research And Treatment Of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

Women or men with pathologic stage II or stage III, early invasive breast cancer according to the UICC 8th edition for TNM classification, Adjuvant chemotherapy indicated and feasible according to treating physician and patient, based on standard clinicopathological parameters (tumor size, lymph node involvement, general health status, proliferation marker, patient wish) and gene expression profile if available., Adjuvant chemotherapy with both anthracycline and taxanes (in combination or in sequence) considered not indicated or not feasible according to treating physician., Age =70 years, WHO Performance status 0-2, Completed G8 geriatric assessment within 3 weeks of randomization, Participation in translational research is mandatory and therefore patient must consent for it. Patient should allow sequential sampling of blood during the course of the trial, Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption., Patient must have undergone breast +/- axillary surgery with curative intent for the current malignancy =12 weeks before randomization. The final primary tumor surgical specimen must have R0 margins free from tumor., Patients must have sufficient resolution of any surgical side effects from the last surgery per physician assessment, with no active wound healing complications at the time of randomization., Incentive to undergo adjuvant radiation therapy when indicated per local institutional guidelines. Note: For patients in the palbociclib arm, radiation therapy when indicated has to start =13 weeks after last surgery. The endocrine therapy can be initiated during or after the radiation therapy but not later than 4 weeks after the last radiotherapy. Palbociclib has to start =4 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy and palbociclib have to be initiated =13 weeks after last surgery. Note: For patients in the chemotherapy arm, chemotherapy has to be the first adjuvant treatment and has to start = 13 weeks after the last surgery. When radiation therapy is indicated, this treatment has to start =9 weeks after the last chemotherapy administration. Adjuvant endocrine therapy can be initiated during or after the radiation therapy but not later than 4 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy has to be initiated =6 weeks after last chemotherapy administration., Adequate baseline organ function, evidenced by the following laboratory results within 3 weeks of randomization: - Hemoglobin = 9 g/dL - Absolute neutrophil count (ANC) = 1500/mm3 - Platelet count = 100,000/mm3 - Total bilirubin = 1.5 upper limit of normal (ULN), or total bilirubin = 3.0 ×ULN in patients with documented Gilbert's Syndrome. - Glomerular Filtration Rate (GFR) = 30 ml/min according to MDRD formula or CKD-EPI formula or Cockcroft and Gault formula - SGOT (AST), SGPT (ALT) and alkaline phosphatase = 2.5 × ULN, For men participating in the trial: • As fertility may be affected permanently with protocol treatment, we advise offering to patient sperm preservation prior to treatment. • With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive** method that together result in a failure rate of <1% per year during the treatment period and for 6 months after the last dose of chemotherapies or 3 months and half (14 weeks) afte

Exclusion Criteria

Evidence of macroscopic distant metastases, investigated according to local institutional guidelines, Concomitant anticancer treatment with the exception of bone antiresorptive agents or LHRH agonists in male patients treated with an aromatase-inhibitor, History of allergic reactions attributed to compounds of chemical or biological composition similar to palbociclib or to chemotherapy components, Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption, Medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization, Patients who received treatment with live vaccines within 30 days prior the first dose of study medication., History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis., Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including known HIV, active hepatitis B and/or hepatitis C infection), symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or uncontrolled diabetes. Note: For patients for whom doxorubicin or epirubicin is planned, an adequate baseline cardiac function (left ventricular ejection fraction = 50%) should have been proven no more than 1 year before treatment start., Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial, Other malignancy within the last 5 years except: adequately treated non-metastatic non-melanoma skin cancer, or successfully treated in situ carcionoma for example curatively treated in situ cancer of the cervix, ductal carcinoma in situ of the breast., Previous history of invasive breast cancer, Systemic anticancer therapy prior to the breast cancer surgery, Prior therapy with any CDK4/6 inhibitor, Concurrent investigational agent within 28 days of randomization or five elimination half-lives, whichever is longer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified