Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Herceptin™ (Her) Drug: Herceptin™ (Her) + chemo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
- Time to progression on combined HerChemo (TTPHerChemo) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Time to first progression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Predictive value of serum HER2/neu ECD levels on clinical outcome [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Conversion rate of estrogen receptor status [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Association of immunoprofiles of erbB-1, erbB-2, erbB-3 and erbB-4 with clinical outcome [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | August 1999 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
|
Drug: 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™+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
|
Drug: 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Italy | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
| Ospedale di Circolo e Fondazione Macchi | |
| Varese, Italy, 21100 | |
| Switzerland | |
| Kantonsspital Aarau | |
| Aarau, Switzerland, CH-5001 | |
| Kantonsspital Baden | |
| Baden, Switzerland, CH-5404 | |
| Universitaetsspital-Basel | |
| Basel, Switzerland, CH-4031 | |
| Inselspital Bern | |
| Bern, Switzerland, CH-3010 | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| Ospedale Beata Vergine | |
| Mendrisio, Switzerland, CH-6850 | |
| Praxis Dr. Beretta | |
| Rheinfelden, Switzerland, CH-4310 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Regionalspital | |
| Thun, Switzerland, 3600 | |
| UniversitaetsSpital Zuerich | |
| Zurich, Switzerland, CH-8091 | |
| Onkozentrum | |
| Zurich, Switzerland, 8038 | |
| Study Chair: | Pagani Olivia, MD | Istituto Oncologico della Svizzera Italiana IOSI |
More Information
No publications provided
| Responsible Party: | Swiss Group for Clinical Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00004935 History of Changes |
| Other Study ID Numbers: | SAKK 22/99, SWS-SAKK-22/99, EU-99028 |
| Study First Received: | March 7, 2000 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Swiss Group for Clinical Cancer Research:
|
stage IV breast cancer recurrent breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013