A Phase 2 interventional study of Herceptin and Navelbine in Breast Cancer, sponsored by Eric Winer, MD. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-09.
Sponsored by Eric Winer, MD · Phase 2, Interventional, and Treatment
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.
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 81 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Eric Winer, MD as lead sponsor.
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Exclusion Criteria:
Herceptin/navelbine
Drug: Herceptin · Drug: Navelbine
Taxotere/carboplatin/herceptin
Drug: Herceptin · Drug: Taxotere · Drug: Carboplatin
One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
Also known as: Trastuzumab
Weekly injections given starting week 3 and ending week 14
Also known as: vinorelbine
Given every three weeks starting week 3 and ending on week 14
Also known as: docetaxel
Given every three weeks starting week 3 and ending on week 14
Also known as: paraplatin
Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
Time frame: 12 weeks
A total of 81 patients were enrolled on the study between 12/2003 and 8/2008.
| Milestone | Herceptin/Navelbine | Taxotere/Carboplatin/Herceptin |
|---|---|---|
| Started | 41 | 40 |
| Completed | 41 | 40 |
| Not completed | 0 | 0 |
Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
| percentage of participants | Arm 1 | Arm 2 |
|---|---|---|
| Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer | 17 | 31 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 5/41 (12.2%) | 27/41 (65.9%) |
| Arm 2 | — | 5/40 (12.5%) | 25/40 (62.5%) |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 4/41 | 4/40 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 0/41 | 1/40 |
| SGPT (ALT)Hepatobiliary disorders | 1/41 | 0/40 |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| NeutropeniaImmune system disorders | 11/41 | 5/40 |
| LeukocytesImmune system disorders | 6/41 | 7/40 |
| SGPT (ALT)Hepatobiliary disorders | 4/41 | 0/40 |
| Irregular MensesReproductive system and breast disorders | 0/41 | 3/40 |
| SGOT (AST)Hepatobiliary disorders | 3/41 | 0/40 |
| Febrile NeutropeniaImmune system disorders | 1/41 | 2/40 |
| FatigueGeneral disorders | 1/41 | 2/40 |
| DiarrheaGastrointestinal disorders | 1/41 | 2/40 |
| AnorexiaGastrointestinal disorders | 0/41 | 2/40 |
| DehydrationBlood and lymphatic system disorders | 0/41 | 2/40 |
| Age Continuous(years) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Mean | 47.8 ± 12.6 | 48.1 ± 8.5 | 48 ± 10.7 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Female | 41 | 40 | 81 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| United States | 41 | 40 | 81 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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