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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)

Status
Closed
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04546009
Protocol IDs
BO41843 (primary)
NCI-2020-08420
2020-000119-66
Study Sponsor
Hoffmann-La Roche

Summary

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

  1. For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
  2. Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  3. Documented ER-positive tumor and HER2-negative tumor, assessed locally
  4. 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
  5. No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
  6. 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
  7. 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
  8. Eastern Cooperative Oncology Group Performance Status 0-1
  9. Adequate organ function

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica


157 Clinic Avenue
Suite 101 and Suite 102
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.