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A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

NCT04546009

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Interventions: Giredestrant, Giredestrant-matched Placebo, Letrozole, Letrozole-matched Placebo, Palbociclib

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (255)
  • Fountain Valley, California, United States
  • Long Beach, California, United States
  • San Leandro, California, United States
  • Stanford, California, United States
  • Walnut Creek, California, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • Fort Myers, Florida, United States
  • Hollywood, Florida, United States
  • Miami, Florida, United States
  • St. Petersburg, Florida, United States
  • Tallahassee, Florida, United States
  • Honolulu, Hawaii, United States
  • Baltimore, Maryland, United States
  • Silver Spring, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Kansas City, Missouri, United States
  • Basking Ridge, New Jersey, United States
  • East Brunswick, New Jersey, United States
  • Montvale, New Jersey, United States
  • Farmington, New Mexico, United States
  • Commack, New York, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Portland, Oregon, United States
  • Charleston, South Carolina, United States
  • Germantown, Tennessee, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • + 225 more on CT.gov