Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:October 2011
End Date:April 2016

Use our guide to learn which trials are right for you!

A Phase II, Double-Blind, Placebo Controlled, Randomized Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy

This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase
II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC)
who have experienced recurrence or progression of their disease while receiving aromatase
inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI
therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have
received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of
this study. Part I of the study will assess the effect of the addition of GDC-0941 to
fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival
(PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the
safety and tolerability and to estimate the effect of GDC-0941 in combination with
fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received
prior treatment with an AI and whose tumors contain a PIK3CA mutation.


Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- As per national or local treatment guidelines, endocrine therapy (i.e., fulvestrant)
is recommended and treatment with cytotoxic chemotherapy is not necessary for
participants, at time of entry into the study.

- Part I: Postmenopausal women with locally ABC or MBC whose disease relapsed during
treatment with (or within 6 months after discontinuation of) an AI in the adjuvant
setting or progressed during treatment with an AI in the metastatic setting.

- Part II: Postmenopausal women with locally ABC or MBC whose disease has progressed
during or after treatment with an AI. Participants who discontinued the AI for
toxicity rather than completion of regimen or for disease progression are not
eligible

- Estrogen receptor (ER)-positive disease and human epidermal receptor 2
(HER2)-negative disease

- Participants must have measurable disease by response evaluation criteria in solid
tumors (RECIST) version (v) 1.1 or bone-only disease with radiologic scans

- Adequate hematologic and end-organ function

Exclusion Criteria:

- Prior treatment with fulvestrant, phosphoinositide 3-kinase (PI3K) inhibitor, or
mechanistic target of rapamycin (mTOR) inhibitor for ABC or MBC

- Prior anti-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1

- Prior treatment with greater than (>) one cytotoxic chemotherapy regimens or
experienced recurrent or progressive disease on > two endocrine therapies for MBC

- Participants requiring anti-hyperglycemic therapy

- Clinically significant cardiac or pulmonary dysfunction

- History of malabsorption syndrome or other condition that would interfere with
enteral absorption

- Clinically significant history of liver disease

- Active uncontrolled autoimmune disease or active inflammatory disease

- Immunocompromised status

- Need for current chronic corticosteroid therapy

- Pregnancy, lactation, or breastfeeding

- Current severe, uncontrolled systemic disease

- Symptomatic hypercalcemia

- Known untreated or active central nervous system (CNS) metastases

- History of other malignancy within the previous 5 years, except for appropriately
treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine
cancer, or patients who have undergone potentially curative therapy with no evidence
of disease and are deemed by the treating physician to be at low risk for recurrence
We found this trial at
42
sites
?
mi
from
San Jose, CA
Click here to add this to my saved trials
Basking Ridge, New Jersey 07920
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Commack, NY
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
?
mi
from
Hayward, CA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Joliet, IL
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Oakland, CA
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rockville Centre, New York 11570
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
?
mi
from
Sleepy Hollow, NY
Click here to add this to my saved trials
South San Francisco, California 94080
?
mi
from
South San Francisco, CA
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials