AN OPEN-LABEL, PHASE Ia/Ib/IIa STUDY OF GDC 0810 SINGLE AGENT OR IN COMBINATION WITH PALBOCICLIB AND/OR AN LHRH AGONIST IN WOMEN WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCER
- Conditions
- Estrogen receptor positive breast cancer10006291
- Registration Number
- NL-OMON45124
- Lead Sponsor
- Genentech, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
Phase IIa Inclusion Criteria:
- Signed and dated informed consent document indicating that the subject (or legally
acceptable representative) has been informed of all the pertinent aspects of the trial prior to
enrollment
- 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 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 0 or 1
- Adequate organ function
- Cohort A only: Confirmed ESR1 mutation of the LBD and presence of measurable
disease as per Response Evaluation Criteria in Solid Tumors (RECIST)
version 1.1 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 prior
treatment with an aromatase inhibitor in the advanced/metastatic
setting
- Cohort B1 only: no prior fulvestrant allowed
- Cohort B2 only: prior fulvestrant allowed
Phase IIa 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 e.g. Crohn*s disease or ulcerative colitis), any active bowel inflammation (including diverticulitis), 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
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Maximum tolerated dose (MTD)<br /><br>2. Incidence of adverse events<br /><br>3. Efficacy (phase II portion only):clinical benefit rate according to<br /><br>RECIST v1.1</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Maximum tolerated dose (MTD)<br /><br>2. Incidence of adverse events<br /><br>3. Efficacy (phase II portion only):clinical benefit rate according to<br /><br>RECIST v1.1</p><br>