Clinical trial · Interventional
A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Participants With Locally Recurrent or Metastatic Breast Cancer
A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
NCT01740336CI-TRIAL-00027149completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in participants with locally recurrent or metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDC-0941 | Drug | Pictilisib | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: Paclitaxel, GDC-0941
- description
- Participants will receive GDC-091 260 milligrams (mg) orally in repeated rounds of once daily (QD) dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 will not be administered (5/7-day schedule). This 5/7-day schedule will be repeated weekly in each 28-day cycle until disease progression or intolerable toxicity. Participants will receive 90 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 3 out of 4 weeks in every 28-day cycle.
- interventionNames
- Drug: GDC-0941
- Drug: Paclitaxel
- type
- PLACEBO_COMPARATOR
- label
- B: Paclitaxel, Placebo
- description
- Participants will receive placebo matching to GDC-0941 on the 5/7-day schedule along with 90 mg/m\^2 IV weekly for 3 out of 4 weeks in every 28-day cycle.
- interventionNames
- Drug: Placebo
- Drug: Paclitaxel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease * Human epidermal growth factor receptor 2 (HER2)-negative and hormone receptor (HR) (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic and end organ function * Women of childbearing potential must agree to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 30 days after the last dose of study treatment or 6 months after discontinuation of paclitaxel, whichever is longer Exclusion Criteria: * Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease * Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor for advanced or metastatic breast cancer * History of intolerance to a taxane-containing therapy * History of 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 autoimmune disease or active inflammatory disease * Immunocompromised status due to current known active infection with human immunodeficiency virus (HIV) or due to the use of immunosuppressive therapies for other conditions * Need for current chronic corticosteroid therapy * Pregnant, lactating, or breastfeeding women * Current severe, uncontrolled systemic disease * Known untreated or active central nervous system (CNS) metastases
References
Publications (1)
- DERIVEDVuylsteke P, Huizing M, Petrakova K, Roylance R, Laing R, Chan S, Abell F, Gendreau S, Rooney I, Apt D, Zhou J, Singel S, Fehrenbacher L. Pictilisib PI3Kinase inhibitor (a phosphatidylinositol 3-kinase [PI3K] inhibitor) plus paclitaxel for the treatment of hormone receptor-positive, HER2-negative, locally recurrent, or metastatic breast cancer: interim analysis of the multicentre, placebo-controlled, phase II randomised PEGGY study. Ann Oncol. 2016 Nov;27(11):2059-2066. doi: 10.1093/annonc/mdw320. Epub 2016 Aug 29. PMID 27573562