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

Phase 3

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Herceptin™ (Her); Drug: Herceptin™ (Her) + chemo

• Registration Number: NCT00004935
• Lead Sponsor: Swiss Group for Clinical Cancer Research

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

In advanced HER2+ breast cancer the impact of combining Trastuzumab (T) and chemotherapy (chemo) versus T alone followed by the addition of chemo at disease progression has not been properly studied.

The trial compared efficacy, toxicity and quality of life of sequential administration of T followed, at progression, by combination with chemo (T\>TChemo) versus the upfront combination of T and chemo (TChemo) in patients with HER2+ advanced breast cancer.

Study Timeline

• Study Start: 1999-08-30
• Study First Submitted: 2000-03-07
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2014-11-06
• Status Verified: 2022-03
• Study Completion: 2022-03-31
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Herceptin™ (Her)	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
Herceptin™+Chemo	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 Outcome Measures

Name	Time	Method
Time to progression on combined HerChemo (TTPHerChemo)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Time to first progression	8 weeks
Time to treatment failure	8 weeks
Overall survival	8 weeks
Adverse events	8 weeks
Conversion rate of estrogen receptor status	8 weeks
Association of immunoprofiles of erbB-1, erbB-2, erbB-3 and erbB-4 with clinical outcome	8 weeks
Response rate	8 weeks
Predictive value of serum HER2/neu ECD levels on clinical outcome	8 weeks

Trial Locations

Locations (17)

Ospedale di Circolo e Fondazione Macchi; 🇮🇹 Varese, Italy

Regionalspital; 🇨🇭 Thun, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

European Institute of Oncology; 🇮🇹 Milan, Italy

Inselspital Bern; 🇨🇭 Bern, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

Praxis Dr. Beretta; 🇨🇭 Rheinfelden, Switzerland

Onkozentrum; 🇨🇭 Zurich, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

City Hospital Triemli; 🇨🇭 Zurich, Switzerland

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Ospedale Regionale di Lugano; 🇨🇭 Lugano, Switzerland

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli; 🇨🇭 Bellinzona, Switzerland

Hopital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland