Resumen

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
Documented ER-positive tumor and HER2-negative tumor, assessed locally
Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
Eastern Cooperative Oncology Group Performance Status 0-1
Adequate organ function

Criterios de exclusión

Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
Prior treatment with a selective estrogen receptor degrader (SERD)
Treatment with any investigational therapy within 28 days prior to study treatment
Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
Pregnant or breastfeeding

Intervenciones

drug

Giredestrant

Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

drug

Giredestrant-matched Placebo

Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

drug

Letrozole

Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

drug

Letrozole-matched Placebo

Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

drug

Palbociclib

Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.

drug

LHRH Agonist

Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Ubicaciones

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Hospital de Onc Angel Roffo

Buenos Aires, Argentina

Organización medica de Investi

Cap Fed, Argentina

Hospital Britanico

Ciudad Autonoma Bs As, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

CEMER Centro Medico de Enfermedades Respiratorias

Vicente López, Argentina

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Giredestrant

Giredestrant-matched Placebo

Letrozole

Letrozole-matched Placebo

Palbociclib

LHRH Agonist

Ubicaciones

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Hospital de Onc Angel Roffo

Organización medica de Investi

Hospital Britanico

Hospital Provincial del Centenario

Instituto de Oncología de Rosario

CEMER Centro Medico de Enfermedades Respiratorias

Patrocinadores