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

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ClinicalTrials.gov Identifier: NCT00004935
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Tracking Information
First Submitted Date  ICMJE March 7, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE August 30, 1999
Actual Primary Completion Date November 6, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
Time to progression on combined HerChemo (TTPHerChemo) [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00004935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • 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 ]
    Toxicity will be graded according to the NCIC-CTG expanded common toxicity grading
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
Official Title  ICMJE 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.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Herceptin™ (Her)
  • 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
    Intervention: Drug: Herceptin™ (Her) + chemo
Publications * Schmid S, Klingbiel D, Aebi S, Goldhirsch A, Mamot C, Munzone E, Nolè F, Oehlschlegel C, Pagani O, Pestalozzi B, Rochlitz C, Thürlimann B, von Moos R, Weder P, Zaman K, Ruhstaller T. Long-term responders to trastuzumab monotherapy in first-line HER-2+ advanced breast cancer: characteristics and survival data. BMC Cancer. 2019 Sep 10;19(1):902. doi: 10.1186/s12885-019-6105-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 8, 2014)
175
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE July 2024
Actual Primary Completion Date November 6, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004935
Other Study ID Numbers  ICMJE SAKK 22/99
SWS-SAKK-22/99 ( Other Identifier: SAKK )
EU-99028 ( Other Identifier: SAKK )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Swiss Group for Clinical Cancer Research
Study Sponsor  ICMJE Swiss Group for Clinical Cancer Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Pagani Olivia, MD Istituto Oncologico della Svizzera Italiana IOSI
PRS Account Swiss Group for Clinical Cancer Research
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP