A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Patients With HER2-Positive Breast Cancer

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00976989
• Other study ID #: BO22280
• Secondary ID: 2009-012019-17
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 14, 2009
• Last updated: December 31, 2015
• Start date: December 2009
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in patients with locally advanced, inflammatory or early stage HER2-positive breast cancer. Before surgery, patients will be randomized to receive either A) 6 cycles of pertuzumab plus Herceptin, with FEC (5-fluorouracil/epirubicin/cyclophosphamide) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus Herceptin with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus Herceptin with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv, then 6mg/kg iv 3-weekly, docetaxel at 75mg/m2 iv, increased to 100mg/m2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery patients will receive Herceptin 6mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female patients, age >/=18 years

• advanced, inflammatory or early stage unilateral invasive breast cancer

• HER2-positive breast cancer

• baseline LVEF >/=55%

Exclusion Criteria:

• metastatic disease (Stage IV) or bilateral breast cancer

• previous anticancer therapy or radiotherapy for any malignancy

• other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma

• clinically relevant cardiovascular disease

• current chronic treatment with corticosteroids of >10mg methylprednisolone or equivalent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• FEC: 5-Fluorouracil/epirubicin/cyclophosphamide
500mg/m2 5-Fluorouracil iv + 100mg/m2 epirubicin iv + 600mg/m2 cyclophosphamide iv 3-weekly, cycles 1-3
• carboplatin
AUC6 (Calvert's Formula) 3-weekly, cycles 1-6
• docetaxel
75mg/m2 iv, escalated to 100mg/m2 iv 3-weekly, cycles 1-6
• docetaxel
75mg/m2 iv, escalated to 100mg/m2 iv 3-weekly, cycles 4-6
• pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly, cycles 1-6
• pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly, cycles 4-6
• trastuzumab
post surgery, 6mg/m2 iv 3-weekly, cycles 7-20
• trastuzumab [Herceptin]
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly, cycles 1-6
• trastuzumab [Herceptin]
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly, cycles 4-6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Bahamas,  Bosnia and Herzegovina,  Brazil,  Canada,  Croatia,  Germany,  Greece,  Italy,  Korea, Republic of,  Mexico,  New Zealand,  Portugal,  Romania,  Serbia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability during neoadjuvant treatment: symptomatic cardiac events, LVEF		throughout cycles 1-6, complete cardiac questionnaire every 3 weeks, LVEF cycles 2, 4 and 6	No
Secondary	Pathological complete response rate		at surgery, after 6 cycles of treatment	No
Secondary	Safety: AEs, laboratory parameters, LVEF, ECG		throughout study, laboratory parameters assessed every 3 weeks, LVEF and ECG every 2-3 cycles	No
Secondary	Clinical response rate, time to response, disease-free survival, progression-free survival, overall survival		throughout study, tumour assessment/breast examination every 3 weeks	No