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

NCT02015676 | Completed Phase 1 Results

• 1 other identifier: M77035
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

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

  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)

Secondary Outcomes (10)

• Time to Disease Progression - Percentage of Participants With an Event

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

• Time to Disease Progression

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

• Time to Treatment Response - Percentage of Participants With an Event

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

• Time to Treatment Response

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

• Duration of Response - Percentage of Participants With an Event

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

Study Arms (2)

Trastuzumab, Myocet, Paclitaxel; Phase I

EXPERIMENTAL

Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m\^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m\^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression.

Drug: trastuzumab; Drug: paclitaxel; Drug: Myocet

Trastuzumab, Myocet, Paclitaxel; Phase II

EXPERIMENTAL

Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m\^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.

Drug: trastuzumab; Drug: paclitaxel; Drug: Myocet

Interventions

trastuzumab DRUG

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

Also known as: Herceptin

Trastuzumab, Myocet, Paclitaxel; Phase I; Trastuzumab, Myocet, Paclitaxel; Phase II

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

Trastuzumab, Myocet, Paclitaxel; Phase I; Trastuzumab, Myocet, Paclitaxel; Phase II

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

Trastuzumab, Myocet, Paclitaxel; Phase I; Trastuzumab, Myocet, Paclitaxel; Phase II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Madrid, 28027, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Paclitaxel; Doxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 19, 2013
• Study Start: July 1, 2001
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 12, 2015
• Results First Posted: March 12, 2015

Record last verified: 2015-02

Locations

ES (1)