Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments herceptin™ (her), herceptin™ (her) + chemo
Phase phase 3
Sponsor Swiss Group for Clinical Cancer Research
Start date August 1999
End date May 2013
Trial size 175 participants
Trial identifier NCT00004935, EU-99028, SAKK 22/99, SWS-SAKK-22/99

Summary

RATIONALE: To compare efficacy, toxicity and quality of life of the sequential administration of Her alone followed, at PD, by the combination with Chemotherapy (Arm A) vs. the upfront combination of Her and Chemotherapy (Arm B) in patients with advanced/metastatic breast cancer.

PURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks; at time of progression add chemotherapy
herceptin™ (her)
Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks; at time of progression add chemotherapy
(Active Comparator)
Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks, and chemotherapy
herceptin™ (her) + chemo
Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks, and chemotherapy

Primary Outcomes

Measure
Time to progression on combined HerChemo (TTPHerChemo)
time frame: 8 weeks

Secondary Outcomes

Measure
Response rate
time frame: 8 weeks
Time to first progression
time frame: 8 weeks
Time to treatment failure
time frame: 8 weeks
Overall survival
time frame: 8 weeks
Toxicity
time frame: 8 weeks
Quality of life
time frame: 8 weeks
Predictive value of serum HER2/neu ECD levels on clinical outcome
time frame: 8 weeks
Conversion rate of estrogen receptor status
time frame: 8 weeks
Association of immunoprofiles of erbB-1, erbB-2, erbB-3 and erbB-4 with clinical outcome
time frame: 8 weeks

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Swiss Group for Clinical Cancer Research.