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A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in 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.

- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer

Outcome Description:

Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Eric Winer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

03-311

NCT ID:

NCT00148668

Start Date:

December 2003

Completion Date:

August 2011

Related Keywords:

  • Breast Cancer
  • HER-2 Positive Breast Cancer
  • herceptin
  • navelbine
  • taxotere
  • carboplatin
  • Early stage Breast Cancer
  • Breast Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Massachusetts General HospitalBoston, Massachusetts  02114-2617