Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00849472 |
The purpose of this study is to determine whether the treatment of a doxorubicin in combination with cyclophosphamide followed by a combination of pazopanib in combination with paclitaxel prior to surgery results in a pathological complete response in females with breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: pazopanib monotherapy Procedure: surgery Drug: doxorubicin + cyclophosphamide Drug: paclitaxel + pazopanib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Clinical Trial of Four Cycles of Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Given Concurrently With Pazopanib as Neoadjuvant Therapy Followed by Postoperative Pazopanib for Women With Locally Advanced Breast Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Treatment Arm: Experimental
Preoperative Cycles 1-4 Doxorubicin 60 mg/m2 IV over 15 minutes + Cyclophosphamide 600 mg/m2 IV over 30 minutes of Day 1 every 21 days followed by: Cycles 5-8 Paclitaxel 80 mg/m2 IV over 60 minutes (Days 1, 8, and 15) every 28 days in combination with pazopanib (800 mg) PO once daily (2 tablets taken at the same time each day either 1 hour before or 2 hours after a meal) Daily beginning on Day 1 of the first paclitaxel cycle Until 7 days before surgery Followed by Surgery Postoperative Pazopanib 800 mg PO once daily (2 tablets taken at the same time each day either 1 hour before or 2 hours after a meal) Daily beginning 4-6 weeks after surgery 6 months from first postoperative dose |
Drug: pazopanib monotherapy
6 months of treatment with pazopanib monotherapy
Procedure: surgery
neoadjuvant surgery for breast cancer
Drug: doxorubicin + cyclophosphamide
4 cycles of doxorubicin + cyclophosphamide followed by 4 cycles of paclitaxel + pazopanib.
Drug: paclitaxel + pazopanib
4 cycles of paclitaxel + pazopanib
|
This is a phase II non-randomized, multi-center study aimed to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel following treatment with cyclophosphamide and doxorubicin for the treatment of neoadjuvant breast cancer.
Patients will receive standard doses of AC every 21 days for 4 cycles. This will be followed by weekly paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with pazopanib 800 mg PO daily starting with the first paclitaxel dose and continuing until 7 days before surgery. Clinical complete response rate will be determined by tumor assessments performed by palpation at two time points: following AC (before paclitaxel/pazopanib begins) and 2-4 weeks following the last dose of paclitaxel (before surgery). Following recovery from preoperative therapy, patients will undergo the clinically-indicated surgery. Pazopanib will resume 4-6 weeks after surgery and continue daily for 6 months of postoperative pazopanib therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, Alabama | |
GSK Investigational Site | Not yet recruiting |
Huntsville, Alabama, United States, 35801 | |
GSK Investigational Site | Not yet recruiting |
Decatur, Alabama, United States, 35601 | |
GSK Investigational Site | Not yet recruiting |
Huntsville, Alabama, United States, 35805 | |
United States, Iowa | |
GSK Investigational Site | Not yet recruiting |
Iowa City, Iowa, United States, 52242 | |
United States, New Jersey | |
GSK Investigational Site | Recruiting |
New Brunswick, New Jersey, United States, 08901 | |
Canada, Quebec | |
GSK Investigational Site | Not yet recruiting |
Montreal, Quebec, Canada, H2L 4M1 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110264, NSABP FB-6 |
Study First Received: | February 12, 2009 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00849472 History of Changes |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration; United States: Institutional Review Board |
Neoadjuvant Breast Cancer Doxorubicin Pazopanib (GW786034) |
Paclitaxel cyclophosphamide NSABP Foundation, Inc. |
Skin Diseases Immunologic Factors Breast Neoplasms Antimitotic Agents Cyclophosphamide Immunosuppressive Agents Doxorubicin Anti-Bacterial Agents |
Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Breast Neoplasms Antimitotic Agents Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |