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Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research Identifier:
First received: March 7, 2000
Last updated: September 30, 2016
Last verified: September 2016

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
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.

Resource links provided by NLM:

Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Time to progression on combined HerChemo (TTPHerChemo) [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 175
Study Start Date: August 1999
Estimated Study Completion Date: June 2018
Primary Completion Date: May 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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 70


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1 OR
  • SAKK 0-1

Life expectancy:

  • At least 12 weeks


  • Hemoglobin at least 10 g/dL
  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 2,000/mm^3


  • 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


  • Creatinine no greater than 1.25 times ULN


  • 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


  • 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


Biologic therapy:

  • Not specified


  • 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)


  • Not specified


  • Not specified


  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004935

Institut Bergonie
Bordeaux, France, 33076
European Institute of Oncology
Milan, Italy, 20141
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Kantonsspital Baden
Baden, Switzerland, CH-5404
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
Thun, Switzerland, 3600
Zurich, Switzerland, 8038
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Pagani Olivia, MD Istituto Oncologico della Svizzera Italiana IOSI
  More Information

Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00004935     History of Changes
Other Study ID Numbers: SAKK 22/99
SWS-SAKK-22/99 ( Other Identifier: SAKK )
EU-99028 ( Other Identifier: SAKK )
Study First Received: March 7, 2000
Last Updated: September 30, 2016

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
Breast Diseases
Skin Diseases
Antineoplastic Agents processed this record on May 25, 2017