Clinical trial NCT02015676: A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
Official title: 'A Study of the Effect of First Line Treatment With Paclitaxel and Myocet in Combination With Herceptin on Overall Tumor Response in Patients With Metastatic or Locally Advanced Breast Cancer and HER2 Overexpression.'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is 3-12 months.


Eligibility criteria: Inclusion Criteria:

* women 18-70 years of age;
* metastatic or locally advanced breast cancer;
* HER2 overexpression;
* \>= 1 measurable lesion.

Exclusion Criteria:

* prior treatment for advanced breast cancer;
* prior treatment with Herceptin;
* bone or central nervous system metastasis as the only site of disease;
* history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.

Primary outcomes:
measure: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
timeFrame: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Secondary outcomes:
measure: Time to Disease Progression - Percentage of Participants With an Event
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
measure: Time to Disease Progression
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
measure: Time to Treatment Response - Percentage of Participants With an Event
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
measure: Time to Treatment Response
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
measure: Duration of Response - Percentage of Participants With an Event
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
measure: Duration of Response
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
measure: Time to Therapy Failure - Percentage of Participants With an Event
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
measure: Time to Therapy Failure
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
measure: Overall Survival
timeFrame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Other outcomes:
Locations:
city: Madrid
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: