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

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ClinicalTrials.gov Identifier: NCT01901146
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Actavis Inc.
Information provided by (Responsible Party):
Amgen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: ABP 980 Drug: Trastuzumab Drug: Paclitaxel Procedure: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 725 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 29, 2013
Actual Primary Completion Date : May 5, 2016
Actual Study Completion Date : January 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

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: 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 Name: Herceptin®

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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901146


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01901146     History of Changes
Other Study ID Numbers: 20120283
2012-004319-29 ( EudraCT Number )
First Posted: July 17, 2013    Key Record Dates
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019
Last Verified: February 2018
Keywords provided by Amgen:
Human Epidermal Growth Factor Receptor 2 (HER2)
Positive Early Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological