A Randomized, Two-arm, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-positive and Hormone Receptor-positive Advanced (Metastatic or Locally Advanced) Breast Cancer.
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Randomized, Two-arm, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-positive and Hormone Receptor-positive Advanced (Metastatic or Locally Advanced) Breast Cancer.
Inclusion Criteria:
- Female adult patients, >/=18 years of age
- Patients with HER2-positive and hormone receptor-positive advanced metastatic or
locally advanced breast cancer
- Post-menopausal status over 1 year
- HER2-positive as assessed by local laboratory on primary or metastatic tumor
- Hormone-receptor positive defined as ER-positive and/or PgR-positive
- At least one measurable lesion and/or non-measurable disease according to Response
Evaluation Criteria In Solid Tumors (RECIST)
Exclusion Criteria:
- Previous systemic non-hormonal anticancer therapy for metastatic or locally advanced
breast cancer
- Previous treatment with anti-HER2 agents for breast cancer
- Disease progression while receiving trastuzumab and/or lapatinib
- Evidence of central nervous system (CNS) metastases in
- Serious uncontrolled concomitant disease except trastuzumab and/or lapatinib in the
neoadjuvant or adjuvant setting
- Disease-free interval from completion of adjuvant/neo-adjuvant treatment to
recurrence within 6 months
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free Survival
Outcome Time Frame:
Up to approximately 49 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
MO27775
NCT ID:
NCT01491737
Start Date:
February 2012
Completion Date:
September 2016
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| New Britain, Connecticut 06052 | |
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Little Rock, Arkansas 72205-7199 | |
| Kansas City, Kansas 66160 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Washington, District of Columbia |
