Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients

Summary

This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel chemotherapy or endocrine therapy given for 12 weeks with a quality of life assessment for 40 additional weeks in patients with operable HER2+/HR+ breast cancer.

Conditions

• Breast Neoplasms

Interventions

DRUG

Perjeta Injectable Product

Single dose of 840mg (loading dose) day1 cycle 1, 420mg at day1 of each subsequent cycle, every 3 weeks. (The latter cycle is called cycle of treatment and is to be given 4 times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)

DRUG

Herceptin

Single dose of 8mg/kg (loading dose) day1 cycle 1; 6mg/kg at day1 of each subsequent cycle body weight every 3 weeks. (This is called cycle of treatment and is to be given four times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)

DRUG

Tamoxifen

20 mg per day for a total of 40 weeks in the adjuvant therapy phase.

DRUG

Paclitaxel

80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment and is to be given for 12 weeks in neoadjuvant therapy phase.

DRUG

Epirubicin

12 weeks (4cycles) of max. 90mg/sqm in adjuvant therapy phase

DRUG

Cyclophosphamide

12 weeks (4cycles) of 600 mg/sqm i.v. on day 1+8 or 12 weeks (4cycles) of 500 mg/sqm i.v. on day 1 in adjuvant therapy phase

DRUG

Anastrozole

1mg per day for a total of 40 weeks in adjuvant therapy phase

DRUG

Letrozole

2,5 mg/day for a total of 40 weeks in adjuvant therapy phase

DRUG

Exemestane

25mg/day for a total of 40 weeks in adjuvant therapy phase

DRUG

Leuprorelin acetate

One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.

DRUG

Goserelin

3,6mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.

DRUG

Anastrozole

1mg per day for 12 weeks in neoadjuvant therapy phase; 1mg per day for a total of 40 weeks max. in adjuvant therapy phase

DRUG

Letrozole

2,5 mg per day for 12 weeks in neoadjuvant therapy phase; 2,5 mg perday for a total of 40 weeks max. in adjuvant therapy phase

DRUG

Exemestane

25mg/day for 12 weeks in neoadjuvant therapy phase; 25mg/day for a total of 40 weeks max. in adjuvant therapy phase

DRUG

Paclitaxel

80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment an is to be given for 12 weeks in the adjuvant phase

DRUG

Tamoxifen

20mg per day (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase.

DRUG

Leuporelin acetate

One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).

DRUG

Goserelin

3,5mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).

DIAGNOSTIC_TEST

Biopsy

Core biopsy at screening (outside of protocol), at week 4 after randomization, (at week 14 in addition if neoadjuvant phase is prolonged)

PROCEDURE

Surgery

Surgery at week 14 after randomization (or later, if neoadjuvant phase is prolonged)

Sponsors & Collaborators

• Roche Pharma AG

  collaborator INDUSTRY

• WSG WOMEN´S HEALTHCARE STUDY GROUP

  collaborator UNKNOWN

• Cankado GmbH

  collaborator INDUSTRY

• Palleos Healthcare GmbH

  lead INDUSTRY

Principal Investigators

• Iris Reiser, PhD · Palleos Healthcare GmbH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-05

Primary Completion

2020-07-14

Completion

2024-03-04

Countries

• Germany

Study Locations