Studieoverzicht - 2011-02 APHINITY

 
Number 2011-02 APHINITY
Nickname APHINITY
Status Follow up Date: 31-08-2013
Inclusion closed
Other study number(s) BIG 4-11/BO25126/TOC4939G
Participating parties/groups Breast International Group; Roche Nederland
Full title A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer
Phase and type Randomized Phase III
Age ≥ 18
Menopausal status Both pre- and postmenopausal
Indication Adjuvant
Subindication HER2+, any HR
Target sample size 4800
Actual accrual 4805 (NL 24) Date: 01-09-2013
Estimated study completion date 31-12-2013
CCMO approval Yes Date: Nr: NL37799.098.11
EudraCT nr. 2010-022902-41
Trial Register NCT01358877
METC approval Yes Date: 08-03-2012 METC: METC Zuidwest Holland Nr: 11-135
Amendments Date:
KWF-CKS approval Not applicable Date: Nr:
News item
Website http://www.bigagainstbreastcancer.org/scientific-projects1/clinical-trials/big-4-11-aphinity
Sponsor Hoffmann-La Roche
Principal Investigator(s) Prof.dr. V.C.G. Tjan-Heijnen (NL)
Study manager E. Kolthof (Roche Nederland B.V.)
A.E. van Leeuwen-Stok (BOOG Study Center)
Central datamanagement and randomization BREAST
Monitoring Roche Nederland B.V.
Local datamanagement
Funding
Extra

Design:

A prospective, two-arm, randomized, multicenter, multinational, double-blind, placebo-controlled study in patients with HER2-positive primary breast cancer who have had excision of their tumor.

Arms

Experimental: 1

  • Drug: pertuzumab
      840 mg iv loading dose in Cycle 1, followed by 420 mg iv every 3 weeks, 52 weeks
  • Drug: trastuzumab [Herceptin]
      8 mg/kg iv loading dose in Cycle 1, followed by 6 mg/kg iv every 3 weeks, 52 weeks
  • Drug: Chemotherapy
      6-8 cycles of standard chemotherapy (non-anthracycline based or anthracycline-based)

Placebo Comparator: 2

  • Drug: placebo
      iv every 3 weeks, 52 weeks
  • Drug: trastuzumab [Herceptin]
      8 mg/kg iv loading dose in Cycle 1, followed by 6 mg/kg iv every 3 weeks, 52 weeks
  • Drug: Chemotherapy
      6-8 cycles of standard chemotherapy (non-anthracycline based or anthracycline-based)
Objectives:

PRIMARY OBJECTIVES
To compare invasive disease-free survival (IDFS) in patients with HER2-positive breast cancer randomized to chemotherapy plus one year of trastuzumab plus placebo or chemotherapy plus one year of trastuzumab plus pertuzumab.


SECONDARY OBJECTIVES
To compare invasive disease-free survival including second non-breast cancers, disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI), distant recurrence-free interval (DRFI), cardiac safety, overall safety and health-related quality of life (HRQL) in the two treatment arms.

Endpoints:

Primary Endpoint

Invasive Disease-free Survival (IDFS)

Secundary Endpoints

  • Invasive Disease-free Survival including second primary non-breast cancer
  • Disease Free Survival (DFS)
  • Overall Survival (OS)
  • Recurrence-free interval (RFI)
  • Distant Recurrence-Free Interval (DRFI)
  • Cardiac and Overall Safety
  • Quality of Life
Main eligibility criteria:

Main inclusion criteria:

  • Adult patients. >/= 18 years of age
  • Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised, and that is either node-positive (except T0) or node-negative but with presence of at least one risk factor as defined by the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status </=1
  • The interval between definitive surgery for breast cancer and randomization must be at least 3 weeks but no more than 7 weeks and the patient must be willing and able to start treatment within 1 week of randomization
  • Known hormone receptor status (estrogen receptor and progesterone receptor)
  • Baseline LVEF >/= 55%
  • Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 6 months after the last dose of study drug

Main exclusion criteria:

  • History of any prior (ipsi- and/or contralateral) invasive breast cancer
  • History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • Any "clinical" T4 tumor as defined by TNM, including inflammatory breast cancer
  • Any previous systemic chemotherapy for cancer or radiotherapy for cancer
  • Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
  • Concurrent anti-cancer treatment in another investigational trial
  • Serious cardiac or cardiovascular disease or condition
  • Pregnant or lactating women
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