A Study of ARN-810 (GDC-0810) Single Agent or in Combination With Palbociclib and/or an LHRH Agonist in Women With Locally Advanced orMetastatic Estrogen Receptor Positive Breast Cancer

Phase 1

• Conditions: Patients with locally advanced or metastatic estrogen receptor (ER) positive breast cancer; MedDRA version: 19.1Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004852-77-NL
• Lead Sponsor: Genentech, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-02
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

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

Inclusion Criteria

General inclusion criteria:
-Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for ER+ breast cancer

- ER-positive, HER2-negative

- At least 2 months must have elapsed from the use of tamoxifen

- At least 6 months must have elapsed from the use of fulvestrant

- At least 2 weeks must have elapsed from the use of any other anticancer hormonal therapy

- At least 3 weeks must have elapsed from the use of any chemotherapy

- Females, 18 years of age or older

- Postmenopausal status

- Eastern Cooperative Oncology Group (ECOG) performance status
- Adequate organ function

Phase II portion - all general above inclusion criteria, plus:

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- At least 6 months must have elapsed from the use of fulvestrant not applicable

and plus:

- Cohort A only: Confirmed ESR1 mutation and presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or evaluable bone disease

- Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from the use of tamoxifen

- Cohort A2 only: prior fulvestrant allowed

- Cohort B only: disease progression following no more than 1 prior treatment with an aromatase inhibitor in the advanced/metastatic setting

- Cohort B1 only: no prior fulvestrant allowed

- Cohort B2 only: prior fulvestrant allowed
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

General exclusion criteria:
- Untreated or symptomatic CNS metastases

- Patients with a history of endometrial polyps, endometrial cancer,
atypical endometrial hyperplasia, or other significant endometrial
disorders should be excluded unless they have undergone total
hysterectomy and there is no evidence of active disease.

- More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred >/= 12 months prior to enrollment)

- Current treatment with any systemic anticancer therapies for advanced disease or any systemic experimental treatment on another clinical trial

- Any significant cardiac dysfunction within 12 months prior to enrollment

- Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection

- Known human immunodeficiency virus infection

- Major surgery within 4 weeks prior to enrollment

- Radiation therapy within 2 weeks prior to enrollment

Phase IIa portion - all general exclusion criteria, plus:

- Cohort A1, A2, and Cohort B2 only: > 1 prior chemotherapy in the advanced/metastatic setting

- Cohort B1 only: prior chemotherapy in the advanced/metastatic setting

Study & Design

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