Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer (Lilac)

June 18, 2019 updated by: Amgen

A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 980 Compared With Trastuzumab in Subjects With HER2 Positive Early Breast Cancer

The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

725

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Brest, Belarus, 224027
        • Research Site
      • Grodno, Belarus, 230017
        • Research Site
      • Minsk, Belarus, 220013
        • Research Site
      • Minsk, Belarus, 223040
        • Research Site
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 41820-021
        • Research Site
    • RIO Grande DO SUL
      • Ijuí, RIO Grande DO SUL, Brazil, 98700-000
        • Research Site
      • Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
        • Research Site
    • SAO Paulo
      • Jaú, SAO Paulo, Brazil, 17210-080
        • Research Site
      • Santo André, SAO Paulo, Brazil, 09060-650
        • Research Site
      • São Paulo, SAO Paulo, Brazil, 04039-004
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Research Site
      • Varna, Bulgaria, 9010
        • Research Site
    • Sofiya
      • Sofia, Sofiya, Bulgaria, 1756
        • Research Site
    • Veliko Turnovo
      • Veliko Tarnovo, Veliko Turnovo, Bulgaria, 5000
        • Research Site
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C6Z8
        • Research Site
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Research Site
  • Chile
      • Santiago, Chile, 8360160
        • Research Site
    • Cautín
      • Temuco, Cautín, Chile, 4810469
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Research Site
    • Brandenburg
      • Fürstenwalde, Brandenburg, Germany, 15517
        • Research Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60389
        • Research Site
      • Frankfurt am Main, Hessen, Germany, 60590
        • Research Site
    • Nordrhein-westfalen
      • Bonn, Nordrhein-westfalen, Germany, 53111
        • Research Site
      • Bottrop, Nordrhein-westfalen, Germany, 46236
        • Research Site
  • Greece
    • Attica
      • Athens, Attica, Greece, 11527
        • Research Site
      • Athens, Attica, Greece, 12462
        • Research Site
    • Crete
      • Heraklion, Crete, Greece, 71110
        • Research Site
    • Nea Efkarpia
      • Thessaloniki, Nea Efkarpia, Greece, 56429
        • Research Site
  • Hungary
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1122
        • Research Site
    • Hajdu-bihar
      • Debrecen, Hajdu-bihar, Hungary, 4032
        • Research Site
    • Jasz-nagykun-szolnok
      • Szolnok, Jasz-nagykun-szolnok, Hungary, 5000
        • Research Site
    • Szabolcs-szatmar-bereg
      • Nyíregyháza, Szabolcs-szatmar-bereg, Hungary, 4400
        • Research Site
    • Tolna
      • Szekszárd, Tolna, Hungary, 7100
        • Research Site
  • Italy
      • Bari, Italy, 74124
        • Research Site
      • Milano, Italy, 20141
        • Research Site
      • Palermo, Italy, 90127
        • Research Site
      • Parma, Italy, 43100
        • Research Site
      • Piacenza, Italy, 29100
        • Research Site
      • Varese, Italy, 21100
        • Research Site
    • Como
      • San Fermo della Battaglia, Como, Italy, 22040
        • Research Site
  • Mexico
      • Queretaro, Mexico, 76090
        • Research Site
      • Toluca, Estado De Mexico, Mexico, 50180
        • Research Site
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64710
        • Research Site
    • SAN LUIS Potosi
      • San Luis Potosí, SAN LUIS Potosi, Mexico, 78200
        • Research Site
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-792
        • Research Site
    • Lubelskie
      • Warszawa, Lubelskie, Poland, 20-090
        • Research Site
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-776
        • Research Site
      • Warszawa, Mazowieckie, Poland, 03-291
        • Research Site
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-219
        • Research Site
    • Slaskie
      • Rybnik, Slaskie, Poland, 44-217
        • Research Site
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-569
        • Research Site
      • Poznań, Wielkopolskie, Poland, 61-485
        • Research Site
  • Romania
      • Brasov, Romania, 500091
        • Research Site
      • Cluj, Romania, 400058
        • Research Site
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Research Site
    • Prahova
      • Ploiesti, Prahova, Romania, 100337
        • Research Site
    • Timis
      • Timisoara, Timis, Romania, 300595
        • Research Site
  • Russian Federation
      • Chelaybinsk, Russian Federation, 454087
        • Research Site
      • Moscow, Russian Federation, 115478
        • Research Site
      • Nizhny Novgorod, Russian Federation, 603081
        • Research Site
      • Pyatigorsk, Russian Federation, 357502
        • Research Site
      • Ryazan, Russian Federation, 390011
        • Research Site
      • Saint Petersburg, Russian Federation, 195271
        • Research Site
      • Saint Petersburg, Russian Federation, 197758
        • Research Site
      • Saint-Petersburg, Russian Federation, 197089
        • Research Site
      • Sochi, Russian Federation, 354057
        • Research Site
    • Kaluzhskaya
      • Obninsk, Kaluzhskaya, Russian Federation, 249036
        • Research Site
    • Mordovia
      • Saransk, Mordovia, Russian Federation, 430032
        • Research Site
    • Moscow
      • Moscow Region, Moscow, Russian Federation, 143423
        • Research Site
    • Primorskiy
      • Arkhangelsk, Primorskiy, Russian Federation, 163045
        • Research Site
    • Yaroslavlr
      • Yaroslavl, Yaroslavlr, Russian Federation, 150054
        • Research Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Research Site
      • Belgrade, Serbia, 11080
        • Research Site
      • Kragujevac, Serbia, 34000
        • Research Site
      • Nis, Serbia, 18000
        • Research Site
      • Sremska Kamenica, Serbia, 21204
        • Research Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Research Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Research Site
      • Cape Town, Western Cape, South Africa, 7700
        • Research Site
  • Spain
      • Barcelona, Spain, 08041
        • Research Site
      • Madrid, Spain, 28050
        • Research Site
      • Madrid, Spain, 28220
        • Research Site
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Research Site
    • LA Coruna
      • A Coruña, LA Coruna, Spain, 15009
        • Research Site
    • Lleida
      • Lérida, Lleida, Spain, 25198
        • Research Site
    • Madrid
      • Alcorcón, Madrid, Spain, 28921
        • Research Site
  • Ukraine
      • Chernivtsi, Ukraine, 58013
        • Research Site
      • Dnipropetrovsk, Ukraine, 49055
        • Research Site
      • Kharkiv, Ukraine, 61070
        • Research Site
      • Lviv, Ukraine, 79031
        • Research Site
      • Zaporizhzhya, Ukraine, 69040
        • Research Site
    • Kiev
      • Kyiv, Kiev, Ukraine, 03115
        • Research Site
    • Transcarpathia
      • Uzhgorod, Transcarpathia, Ukraine, 88000
        • Research Site
    • Volyn
      • Lutsk, Volyn, Ukraine, 43018
        • Research Site
  • United Kingdom
    • England
      • Nottingham, England, United Kingdom, NG5 1PB
        • Research Site
      • Peterborough, England, United Kingdom, PE3 9GZ
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females ≥ 18 years of age
  • Histologically confirmed invasive breast cancer
  • Planning for surgical resection of breast tumor and sentinel node or axillary lymph node resection
  • Planning neoadjuvant chemotherapy
  • HER2 positive disease
  • Measurable disease in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm
  • Known estrogen receptor (ER) and progesterone receptor (PR) hormone receptor status at study entry
  • Normal bone marrow function
  • Normal hepatic function
  • Normal renal function
  • Subjects must sign an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form before any study specific procedures

Inclusion Criteria for Randomization:

  • Left ventricular ejection fraction (LVEF) of ≥55% by 2D echocardiogram
  • Complete all 4 cycles of run-in chemotherapy

Exclusion Criteria:

  • Bilateral breast cancer
  • Presence of known metastases
  • Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer
  • Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • Pre-existing clinically significant (≥ grade 2) peripheral neuropathy
  • Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension
  • Severe dyspnea at rest requiring supplementary oxygen therapy
  • History of positivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV)
  • Recent infection requiring a course of systemic anti-infectives that were completed ≤ 14 days before enrollment (with the exception of uncomplicated urinary tract infection)
  • Woman of childbearing potential who is pregnant or is breast feeding
  • Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence [periodic abstinence (eg calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of the protocol specified treatment
  • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study
  • Other investigational procedures while participating in this study are excluded
  • Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients
  • Subject previously has enrolled and/or has been randomized in this study
  • Subject likely to not be available to complete all protocol required study visits or procedures
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ABP 980

Participants received ABP 980 at an initial dose of 8 mg/kg by intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles during the neoadjuvant phase.

Surgery (lumpectomy or mastectomy with sentinel lymph node dissection or axillary lymph node dissection) was completed 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase.

After surgery (adjuvant phase) participants continued receiving 6 mg/kg ABP 980 IV Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
Drug: ABP 980
ABP 980 was administered at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.
Drug: Paclitaxel
Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care).
Procedure: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection
ACTIVE_COMPARATOR: Trastuzumab

Participants received trastuzumab at an initial dose of 8 mg/kg IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles during the neoadjuvant phase.

Surgery (lumpectomy or mastectomy with sentinel lymph node dissection or axillary lymph node dissection) was completed 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase.

After surgery (adjuvant phase) participants were re-randomized to either continue receiving 6 mg/kg trastuzumab IV Q3W or transition to 6 mg/kg ABP 980 IV Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
Drug: Paclitaxel
Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care).
Procedure: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection
Drug: Trastuzumab
Trastuzumab was administered at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.
Other Names:
  • Herceptin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Pathologic Complete Response
Time Frame: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase

Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS).

Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.
3 to 7 weeks after the last dose of study drug in the neoadjuvant phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Pathologic Complete Response in Breast Tissue Only
Time Frame: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase

Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue, regardless of residual ductal carcinoma in situ (DCIS).

Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.
3 to 7 weeks after the last dose of study drug in the neoadjuvant phase
Percentage of Participants With a Pathologic Complete Response in Breast Tissue and Axillary Lymph Nodes and Absence of DCIS
Time Frame: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase

Pathological complete response was defined as the absence of invasive tumor cells in the breast tissue and axillary lymph node(s) and absence of residual DCIS.

Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.
3 to 7 weeks after the last dose of study drug in the neoadjuvant phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

Actavis Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 29, 2013

Primary Completion (ACTUAL)

May 5, 2016

Study Completion (ACTUAL)

January 27, 2017

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (ESTIMATE)

July 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120283
  • 2012-004319-29 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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