THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: trastuzumab; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448279

ML18742

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients, >=18 years of age;
• metastatic breast cancer;
• HER2 overexpression (IHC 3+ and/or FISH positive);
• disease progression during or after previous 1st line chemotherapy plus Herceptin;
• scheduled to receive 2nd line chemotherapy.

Exclusion criteria

• incompatibility with previous Herceptin therapy;
• pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

58 participants in 2 patient groups

Chemotherapy Alone

Active Comparator group

Description:

Chemotherapy, schedule and dose at the investigator's discretion.

Treatment:

Drug: Chemotherapy

Chemotherapy, Trastuzumab

Experimental group

Description:

Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion.

Treatment:

Drug: trastuzumab

Drug: Chemotherapy