A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:April 9, 2015
End Date:July 3, 2021

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A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

This international, multicenter, randomized, double-blinded, placebo-controlled study is
designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo +
fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal
growth factor receptor-2 (HER2)-negative, oncogene that encodes for
phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally
advanced or metastatic breast cancer after recurrence or progression during or after an
aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm
versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant
tumors via central testing. The anticipated duration of the study is approximately 3.5 years.


Inclusion Criteria:

- Postmenopausal women with histologically or cytologically confirmed locally advanced
or metastatic estrogen receptor (ER) positive breast cancer

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended
and treatment with cytotoxic chemotherapy is not indicated at time of entry into the
study

- 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 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or
progression while on or within 1 month of the end of prior AI treatment for locally
advanced or metastatic breast cancer

- Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version
1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone
lesion via RECIST v1.1

- Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block
(preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from
the most recently collected, available tumor tissue for oncogene that encodes for
phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing

- A valid cobas PIK3CA mutation result by central testing is required

- Adequate hematologic and end-organ function within 28 days prior to treatment
initiation

Exclusion Criteria:

- Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory
testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization
positive)

- Prior treatment with fulvestrant

- Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian
target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT)
inhibitor

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

- Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1

- All acute treatment-related toxicity must have resolved to Grade less than or equal to
(
- Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic
breast cancer

- Concurrent hormone replacement therapy

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

- Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications

- History of inflammatory bowel disease or active bowel inflammation

- Clinically significant cardiac or pulmonary dysfunction

- Clinically significant history of liver disease, including cirrhosis, current alcohol
abuse, or current known active infection with human immunodeficiency virus (HIV),
hepatitis B or C virus
We found this trial at
24
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777 Broadway
Sleepy Hollow, New York 10591
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1835 Savoy Drive
Atlanta, Georgia 30341
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15945 Clayton Rd
Ballwin, Missouri 63011
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Basking Ridge, New Jersey 07920
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Beaverton, OR
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450 Brookline Avenue
Boston, Massachusetts 02215
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Boston, MA
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Commack, New York 11725
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Commack, NY
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Harrisburg, Pennsylvania 17043
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Harrisburg, PA
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Harrison, NY
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Harvey, Illinois 60426
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Harvey, IL
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Lake Success, New York 11042
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Lake Success, NY
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1 Campbell Street
Liverpool, New South Wales 2170
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Liverpool,
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Marietta, Georgia 30060
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Marietta, GA
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480 Red Hill Road
Middletown, New Jersey 07748
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Middletown, NJ
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800 East 28th Street
Minneapolis, Minnesota 55407
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Minneapolis, MN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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9905 Medical Center Drive
Rochville, Maryland 20850
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Rochville, MD
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6435 Chippewa Street
Saint Louis, Missouri 63109
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Saint Louis, MO
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615 South New Ballas Road
Saint Louis, Missouri 63141
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Saint Louis, MO
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1100-A North Tustin Avenue
Santa Ana, California 92705
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Santa Ana, CA
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Tucson, Arizona 85710
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Tucson, AZ
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Tucson, Arizona 85745
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Uniondale, New York 11553
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Uniondale, NY
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