A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer

Breast Cancer Clinical Trial

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.'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015676
• Other study ID #: M77035
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 3, 2013
• Last updated: February 26, 2015
• Start date: July 2001
• Est. completion date: September 2009

Study information

• Verified date: February 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española del Medicamento, Ministerio de Sanidad y Consumo
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• trastuzumab
Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
• paclitaxel
60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression
• Myocet
40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment	For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.	Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Time to Disease Progression - Percentage of Participants With an Event	Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a =25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of =1 cm^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of =50% in existent lesions.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Time to Disease Progression	The median time, in months, from the start of treatment to disease progression event.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Time to Treatment Response - Percentage of Participants With an Event	Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Time to Treatment Response	The median time, in months, from the start of treatment to treatment response event.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Duration of Response - Percentage of Participants With an Event	Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a =25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of =1 cm^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of =50% in existent lesions.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Duration of Response	The median time, in months, from enrollment to duration of response event to Week 52.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Time to Therapy Failure - Percentage of Participants With an Event	Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Time to Therapy Failure	The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Overall Survival (OS) - Percentage of Participants With an Event	OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No
Secondary	Overall Survival	The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.	BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)	No