A Study of GDC-0810 versus Fulvestrant in Postmenopausal Women with Advanced or Metastatic ER+/HER2- Breast Cancer Resistant To Aromatase Inhibitor Therapy

Phase 1

• Conditions: Advanced or Metastatic ER+/HER2- Breast Cancer; MedDRA version: 18.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000106-19-DE
• Lead Sponsor: Genentech, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-26
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

- Postmenopausal women with histologically or cytologically confirmed invasive, estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) (defined by local guidelines) metastatic or inoperable (not amenable to resection or other local therapy with curative intent), locally advanced breast cancer
- Patients for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
- Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
- Radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or MBC
- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or non-measurable, evaluable disease with at least one evaluable bone lesion by RECIST v1.1 based on radiologic scans within 28 days of Day 1 of Cycle 1
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate hematologic and end-organ function

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

- HER2 positive disease (immunohistochemistry [IHC] 3+ staining, fluorescence in situ hybridization [FISH] positive, and/or chromogenic in situ hybridization [CISH] positive)
- Prior treatment with fulvestrant
- Prior anti-cancer therapy within 2 weeks prior to Cycle 1 Day 1
- Prior radiation therapy within 2 weeks prior to Cycle 1 Day 1
- Prior treatment with >1 cytotoxic chemotherapy regimens or >2 endocrine therapies for advanced or metastatic disease
- Ongoing, acute treatment-related toxicity that has not resolved to Grade <=1 or been deemed stable by the investigator
- Concurrent hormone replacement therapy
- Known untreated or active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- History of other malignancy within the previous 5 years
- Inability or unwillingness to swallow pills or receive intramuscular injections
- Clinically significant cardiac or pulmonary dysfunction
- Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of the need for major surgery during the course of study treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified