Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer

NCT02625441 | Active Not Recruiting Phase 3

• 2 other identifiers: FBCG-01-20152015-002323-25
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial compares two systemic treatments for HER2-positive breast cancer. The treatments are given either prior to breast surgery (as neoadjuvant treatment) or after breast surgery (as adjuvant treatment). In the investigational group (Group A) the study participants will receive a combination of two drugs directed at HER2 (two anti-HER2 antibodies) plus a chemotherapy agent (docetaxel) for a brief duration, and the patients allocated to the comparator group (Group B) will be treated with chemotherapy plus one anti-HER2 treatment (trastuzumab) for one year.

Conditions

Breast Cancer

Keywords

Breast cancer; docetaxel; pertuzumab; trastuzumab; HER2

Outcome Measures

Primary Outcomes (1)

• Invasive disease-free survival

  Time from the date of randomization to cancer recurrence or death.

  7 years

Secondary Outcomes (4)

• Overall survival

  7 years

• Distant disease-free survival

  7 years

• Left ventricle ejection fractions

  3 years

• Adverse events of the treatments

  7 years

Study Arms (2)

Short anti-HER2 treatment

EXPERIMENTAL

Pertuzumab 840 mg, i.v., then 420 mg i.v., 3-weekly for 3 cycles; Trastuzumab 8 mg/kg, i.v., then 6 mg/kg, 3-weekly for 3 cycles; Docetaxel 75 mg/m2, i.v., 3-weekly for 3 cycles

Drug: Pertuzumab

Standard anti-HER2 treatment

ACTIVE COMPARATOR

Trastuzumab 8 mg/kg, i.v., then 6 mg/kg, 3-weekly for 3 cycles; Docetaxel 75 mg/m2, i.v., 3-weekly for 3 cycles; Trastuzumab 6 mg/kg, i.v., 3-weekly for for a total duration of one year

Drug: Trastuzumab

Interventions

Pertuzumab DRUG

Pertuzumab 420 mg i.v. 3-weekly for 3 cycles

Also known as: Perjeta

Short anti-HER2 treatment

Trastuzumab DRUG

Trastuzumab 6 mg/kg, i.v., 3-weekly for for a total duration of one year

Also known as: Herceptin

Standard anti-HER2 treatment

Eligibility Criteria

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

You may qualify if:

• Patient has provided a written informed consent prior to study-specific screening procedures, with the understanding that she has the right to withdraw from the study at any time, without prejudice.
• Woman \> 18 years of age.
• Histologically confirmed invasive breast cancer.
• HER2-positive breast cancer (preferably assessed with in situ hybridization; CISH, FISH or SISH; if not available with immunohistochemistry 3+)
• A high risk of breast cancer recurrence with one of the following: i) Pathological N0 with the longest invasive tumor diameter \>10 mm; ii) Histologically confirmed regional node positive disease

You may not qualify if:

• Presence of distant metastases.
• Inflammatory breast cancer.
• Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
• Left ventricular ejection fraction less than 50% (or under the institutional normal reference range) assessed by echocardiography or isotope cardiography.
• ER and HER-2 status (via in situ hybridization or immunohistochemistry) not determined.
• The WHO performance status \> 1.
• Pregnant or lactating women.
• Women of childbearing potential unless using a reliable and appropriate contraceptive method. Women must have been amenorrheic for at least 12 months prior to study entry to be considered postmenopausal and to have no childbearing potential. Women of childbearing potential (menstruating within 12 months of study entry), or with no hysterectomy and age \< 55, must have a negative pregnancy test at baseline.
• Randomization more than 12 weeks after the date of breast surgery.
• Organ allografts with immunosuppressive therapy required.
• Major surgery (except breast surgery) within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
• Participation in any investigational drug study within 4 weeks preceding treatment start.
• Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding study participation.
• Multifocal breast cancer when the largest cancer focus is not HER2-positive.
• History of another malignancy or contralateral invasive breast cancer within the last five years except cured basal cell carcinoma of skin or carcinoma in situ of the uterine cervix (exception: patients with bilateral HER2-positive breast cancer are eligible).

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab; Trastuzumab

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

Study Officials

• Heikki Joensuu, M.D.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Research Director

Study Record Dates

• First Submitted: December 5, 2015
• First Posted: December 9, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)