Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
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Purpose
The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Herceptin Drug: Navelbine Drug: Taxotere Drug: Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer |
- Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
| Enrollment: | 81 |
| Study Start Date: | December 2003 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Herceptin/navelbine
|
Drug: Herceptin
One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
Other Name: Trastuzumab
Drug: Navelbine
Weekly injections given starting week 3 and ending week 14
Other Name: vinorelbine
|
|
Active Comparator: Arm 2
Taxotere/carboplatin/herceptin
|
Drug: Herceptin
One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
Other Name: Trastuzumab
Drug: Taxotere
Given every three weeks starting week 3 and ending on week 14
Other Name: docetaxel
Drug: Carboplatin
Given every three weeks starting week 3 and ending on week 14
Other Name: paraplatin
|
Detailed Description:
Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed.
Patients will be placed into one of 2 arms.
- Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of taxotere/carboplatin/herceptin.
- Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each cycle.
Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine.
Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin.
Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with stage II or III breast cancer
- HER-2 positive tumors
- Older than 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.
- ANC > 1,500/mm3
- Hemoglobin > 9gm/dl
- Platelets > 100,000mm3
- Creatinine < 2mg/dl
- Glucose < 200mg/dl
- Bilirubin < 1.5 x ULN
Exclusion Criteria:
- Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
- Pregnant or breast-feeding women
- Serious illness, or medical or psychiatric condition
- Uncontrolled infections
- Active or severe cardiovascular or pulmonary disease
- Patients with left ventricular ejection fraction < 50%
- Peripheral neuropathy of any etiology that exceeds grade 1
- Prior history of malignancy
- Uncontrolled diabetes
Contacts and Locations| United States, Connecticut | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Eric Winer, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Eric Winer, MD, Chief Division of Women's Cancers, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00148668 History of Changes |
| Other Study ID Numbers: | 03-311 |
| Study First Received: | September 7, 2005 |
| Results First Received: | December 19, 2012 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
HER-2 Positive Breast Cancer herceptin navelbine |
taxotere carboplatin Early stage Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Vinorelbine Docetaxel |
Trastuzumab Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013