A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/19/2018
Start Date:February 17, 2015
End Date:August 2, 2017

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A Phase II Randomized, Double-Blind, Study of Ipatasertib (GDC-0068), an Inhibitor to AKT, in Combination With Paclitaxel as Neoadjuvant Treatment for Patients With Early Stage Triple Negative Breast Cancer

This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II
study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy
versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa
triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.


Inclusion Criteria:

- Premenopausal or postmenopausal women

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

- Histologically documented, Stage Ia to operable Stage IIIa, triple-negative carcinoma
of the breast with primary tumor greter than or equal to (>/=) 1.5 centimeters (cm) in
largest diameter (cT1-3) by MRI

- Adequate hematologic and organ function within 14 days before the first study
treatment

- Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy
of breast primary tumor

- For female participants of childbearing potential, agreement to use highly effective
form(s) of contraception for the duration of the study and for at least 6 months after
last dose of study treatment

Exclusion Criteria:

- Known human epidermal growth factor 2 (HER2)-positive, estrogen receptor
(ER)-positive, or progesterone receptor (PgR)-positive breast cancer

- Any prior treatment for the current primary invasive breast cancer

- Participants with cT4 or cN3 stage breast tumors

- Metastatic (Stage IV) breast cancer

- Bilateral invasive breast cancer

- Multicentric breast cancer

- Any disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that contraindicates the use of an investigational drug or that may
affect the interpretation of the results or render the participant at high risk from
treatment complications
We found this trial at
17
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Austin, Texas 78731
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Austin, TX
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Austin, Texas 78731
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Austin, TX
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2095 Henry Tecklenburg Drive
Charleston, South Carolina 29414
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Charleston, SC
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Charlotte, North Carolina 28203
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Charlotte, NC
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Dallas, TX
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102-104 Endicott Street
Danvers, Massachusetts 01923
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Danvers, MA
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925 Gessner Road
Houston, Texas 77024
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Houston, TX
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Irving, Texas 75063
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Irving, TX
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11750 West 2nd Place
Lakewood, Colorado 80228
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Lakewood, CO
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Lisboa,
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McAllen, TX
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Omaha, NE
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5050 Northeast Hoyt Street
Portland, Oregon 97213
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Portland, OR
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Santa Barbara, California 93105
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Santa Barbara, CA
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Tacoma, Washington 98405
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Tacoma, WA
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Tucson, Arizona 85715
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Tucson, AZ
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