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Randomized Phase III Trial of Herceptin® Followed by Chemotherapy Plus Herceptin® Versus the Combination of Herceptin® and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing Advanced/Metastatic Breast Cancer.


Phase 3
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Randomized Phase III Trial of Herceptin® Followed by Chemotherapy Plus Herceptin® Versus the Combination of Herceptin® and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing Advanced/Metastatic Breast Cancer.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed HER2-overexpressing metastatic breast carcinoma

- Clinically or radiologically measurable or evaluable disease

- Bidimensionally or unidimensionally measurable lesions

- No ascitic, pleural, or pericardial effusions, osteoblastic bone metastases, or
carcinomatous lymphangitis of the lung as only indicator lesion

- No known clinical brain or meningeal involvement

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 to 70

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- ECOG 0-1 OR

- SAKK 0-1

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Hemoglobin at least 10 g/dL

- Platelet count at least 100,000/mm^3

- Absolute neutrophil count at least 2,000/mm^3

Hepatic:

- Bilirubin normal

- SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN) (3 times ULN if
proven liver metastases) OR

- No SGOT and/or SGPT greater than 1.5 times ULN if alkaline phosphatase greater than
2.5 times ULN

Renal:

- Creatinine no greater than 1.25 times ULN

Cardiovascular:

- LVEF normal

- No history of atrial ventricular arrhythmia, congestive heart failure, or angina
pectoris, even if medically controlled

- No history of second or third-degree heart blocks

- No uncontrolled hypertension

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No pre-existing motor or sensory neuropathy grade 2 or greater

- No psychiatric disorder that would preclude informed consent

- No other prior malignancy except curatively treated nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No definite contraindications for use of corticosteroids

- No other concurrent serious illness or medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Prior adjuvant or neoadjuvant chemotherapy allowed

- No more than 2 prior chemotherapy regimens for metastatic disease

- No prior cumulative dose of doxorubicin greater than 240 mg/m^2

- No prior cumulative dose of epirubicin greater than 360 mg/m^2

- No prior taxanes

Endocrine therapy:

- Prior hormonal therapy as adjuvant treatment or for metastatic disease allowed

- No concurrent corticosteroids unless started more than 6 months prior to study and at
low doses (i.e., no greater than 20 mg methylprednisolone or equivalent)

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No other concurrent anticancer drugs

- No other concurrent experimental drugs

- No concurrent bisphosphonates unless initiated more than 3 months prior to study

- Chronic use allowed provided bone metastases are not sole indicator lesions

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression on combined HerChemo (TTPHerChemo)

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Pagani Olivia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Istituto Oncologico della Svizzera Italiana IOSI

Authority:

Switzerland: Swissmedic

Study ID:

SAKK 22/99

NCT ID:

NCT00004935

Start Date:

August 1999

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

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