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A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04961996
Protocol IDs
GO42784 (primary)
NCI-2021-09253
2021-000129-28
Study Sponsor
Hoffmann-La Roche

Summary

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the
efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's
choice in participants with medium- and high-risk Stage I-III histologically confirmed
estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative
early breast cancer.

Eligibility

  1. Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen
  2. Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity
  3. Participants must have undergone definitive surgery of the primary breast tumor(s).
  4. Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization.
  5. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade =2 peripheral neuropathy, arthralgia or other toxicities not considered a safety risk for the participant per the investigator's judgment)
  6. Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery
  7. Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing (i.e., representative archived formalin-fixed, paraffin-embedded [FFPE] tissue block [preferred] or 15-20 slides containing unstained, freshly cut, serial sections), with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study.
  8. Participants with node-positive and node-negative disease are eligible provided they meet additional risk criteria as defined in the protocol
  9. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
  10. Able and willing to swallow, retain, and absorb oral medication
  11. Adequate organ function

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell


1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Doctors:

Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen


200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton


157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville


100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Doctors:

Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Doctors:

Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper


1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Marietta


340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Paulding


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 - Villa Rica


705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Doctors:

Randall E. Pierce MD
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