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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)

Cancer Type
Breast Cancer
Trial Phase
Phase III
18 Years and older, Male and Female
Study Type
Protocol IDs
GO42784 (primary)
Study Sponsor
Hoffmann-La Roche


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.

In addition, an open-label exploratory substudy will explore the safety and efficacy of
giredestrant in combination with abemaciclib in a subset of the primary study population.


  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 their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection [ALND] and/or sentinel lymph node biopsy [SLNB])
  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 Substudy Inclusion Criteria: To be eligible for substudy participation, in addition to meeting the inclusion criteria in the primary protocol, participants must also meet the following modified criteria:
  12. Patients who received adjuvant radiotherapy must have completed radiotherapy prior to enrollment, and patients must have recovered (to Grade =1) from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment. Primary Study

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell

1700 Hospital South Drive
Suite 300
Austell, GA 30106


Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen

200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110


Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton

157 Clinic Avenue
Suite 101
Carrollton, GA 30117


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

Northwest Georgia Oncology Centers - Cartersville

100 Market Place Boulevard
Suite 200
Cartersville, GA 30121


Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville

6002 Professional Parkway
Suite 220
Douglasville, GA 30134


Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper

1020 J.L. White Drive
Suite 160
Jasper, GA 30143


Curtis R. Miles MD

Northwest Georgia Oncology Centers - Marietta

340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060

Northwest Georgia Oncology Centers - Paulding

144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141


Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica

705 Dallas Highway
Suite 204
Villa Rica, GA 30180


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.