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Completed

NCT Number: NCT02015676

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Madrid, 28027, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trastuzumab

Drug

Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression

Other names: Herceptin

paclitaxel

Drug

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

Drug

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

Primary outcomes

  1. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment

    Time frame: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    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.

Secondary outcomes

  1. Time to Disease Progression - Percentage of Participants With an Event

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    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.

  2. Time to Disease Progression

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    The median time, in months, from the start of treatment to disease progression event.

  3. Time to Treatment Response - Percentage of Participants With an Event

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.

  4. Time to Treatment Response

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    The median time, in months, from the start of treatment to treatment response event.

  5. Duration of Response - Percentage of Participants With an Event

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    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.

  6. Duration of Response

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    The median time, in months, from enrollment to duration of response event to Week 52.

  7. Time to Therapy Failure - Percentage of Participants With an Event

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    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.

  8. Time to Therapy Failure

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    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.

  9. Overall Survival (OS) - Percentage of Participants With an Event

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    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.

  10. Overall Survival

    Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.'

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Dec 19, 2013
Registry last updated
Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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