Breast CancerPhase 3LilacNCT01901146

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

A Phase 3 study testing ABP 980, Trastuzumab and Paclitaxel in people with Breast Cancer, run by Amgen at 98 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: ABP 980, Trastuzumab and Paclitaxel
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 725 participants
Where: 98 sitesin 18 countries
Study dates: 29 Apr 2013to 27 Jan 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 13Show fewer

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

98 sites in 18 countries.

Country

City, postcode or hospital

98 sites in 18 countries

Russia14 sites

Research Site
Arkhangelsk, Primorskiy (Maritime) Kray, 163045
Research Site
Chelaybinsk, 454087
Research Site
Moscow, 115478
Research Site
Moscow Region, Moscow, 143423
Research Site
Nizhny Novgorod, 603081
Research Site
Obninsk, Kaluzhskaya, 249036
Research Site
Pyatigorsk, 357502
Research Site
Ryazan, 390011
Research Site
Saint Petersburg, 195271
Research Site
Saint Petersburg, 197089
Research Site
Saint Petersburg, 197758
Research Site
Saransk, Respublika Mordoviya, 430032
Research Site
Sochi, 354057
Research Site
Yaroslavl, Yaroslavlr, 150054

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Poland8 sites

Research Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-792
Research Site
Gdansk, Pomeranian Voivodeship, 80-219
Research Site
Poznan, Greater Poland Voivodeship, 60-569
Research Site
Poznan, Greater Poland Voivodeship, 61-485
Research Site
Rybnik, Silesian Voivodeship, 44-217
Research Site
Warsaw, Masovian Voivodeship, 02-776
Research Site
Warsaw, Masovian Voivodeship, 03-291
Research Site
Warszawa, Lublin Voivodeship, 20-090

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Ukraine8 sites

Research Site
Chernivtsi, 58013
Research Site
Dnipropetrovsk, 49055
Research Site
Kharkiv, 61070
Research Site
Kyiv, Kyiv City, 03115
Research Site
Lutsk, Volyn Oblast, 43018
Research Site
Lviv, 79031
Research Site
Uzhhorod, Zakarpattia Oblast, 88000
Research Site
Zaporizhzhya, 69040

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Italy7 sites

Research Site
Bari, 74124
Research Site
Milan, 20141
Research Site
Palermo, 90127
Research Site
Parma, 43100
Research Site
Piacenza, 29100
Research Site
San Fermo della Battaglia, COMO, 22040
Research Site
Varese, 21100

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Spain7 sites

Research Site
A Coruña, LA Coruna, 15009
Research Site
Alcorcón, Madrid, 28921
Research Site
Barcelona, 08041
Research Site
Lleida, Lleida, 25198
Research Site
Madrid, 28050
Research Site
Madrid, 28220
Research Site
Sabadell, Barcelona, 08208

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Brazil6 sites

Research Site
Ijuí, Rio Grande do Sul, 98700-000
Research Site
Jaú, São Paulo, 17210-080
Research Site
Porto Alegre, Rio Grande do Sul, 91350-200
Research Site
Salvador, Estado de Bahia, 41820-021
Research Site
Santo André, São Paulo, 09060-650
Research Site
São Paulo, São Paulo, 04039-004

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Germany6 sites

Research Site
Berlin, 13353
Research Site
Bonn, North Rhine-Westphalia, 53111
Research Site
Bottrop, North Rhine-Westphalia, 46236
Research Site
Frankfurt am Main, Hesse, 60389
Research Site
Frankfurt am Main, Hesse, 60590
Research Site
Fürstenwalde, Brandenburg, 15517

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Hungary6 sites

Research Site
Budapest, 1083
Research Site
Budapest, 1122
Research Site
Debrecen, Hajdú-Bihar, 4032
Research Site
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
Research Site
Szekszárd, Tolna County, 7100
Research Site
Szolnok, Jász-Nagykun-Szolnok, 5000

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Romania5 sites

Research Site
Brasov, 500091
Research Site
Cluj-Napoca, Cluj, 400006
Research Site
Cluj-Napoca, 400058
Research Site
Ploieşti, Prahova, 100337
Research Site
Timișoara, Timiș County, 300595

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Serbia5 sites

Research Site
Belgrade, 11000
Research Site
Belgrade, 11080
Research Site
Kamenitz, 21204
Research Site
Kragujevac, 34000
Research Site
Niš, 18000

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Belarus4 sites

Research Site
Brest, 224027
Research Site
Grodno, 230017
Research Site
Minsk, 220013
Research Site
Minsk, 223040

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Bulgaria4 sites

Research Site
Pleven, 5800
Research Site
Sofia, Sofia, 1756
Research Site
Varna, 9010
Research Site
Veliko Tarnovo, Veliko Tarnovo, 5000

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Greece4 sites

Research Site
Athens, Attica, 11527
Research Site
Athens, Attica, 12462
Research Site
Heraklion, Crete, 71110
Research Site
Thessaloniki, Nea Efkarpia, 56429

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Mexico4 sites

Research Site
Monterrey, Nuevo León, 64710
Research Site
Querétaro, 76090
Research Site
San Luis Potosí City, San Luis Potosí, 78200
Research Site
Toluca, Estado de Mexico, Mexico, 50180

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South Africa4 sites

Research Site
Cape Town, Western Cape, 7405
Research Site
Cape Town, Western Cape, 7700
Research Site
Durban, KwaZulu-Natal, 4091
Research Site
Johannesburg, Gauteng, 2193

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Canada2 sites

Research Site
Moncton, New Brunswick, E1C6Z8
Research Site
Montreal, Quebec, H1T 2M4

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Chile2 sites

Research Site
Santiago, 8360160
Research Site
Temuco, Cautín, 4810469

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United Kingdom2 sites

Research Site
Nottingham, England, NG5 1PB
Research Site
Peterborough, England, PE3 9GZ

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About this study

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

Conditions: Breast Cancer
Being tested: ABP 980, Trastuzumab, Paclitaxel, Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection
Keywords: Human Epidermal Growth Factor Receptor 2 (HER2), Positive Early Breast Cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABP 980Drug
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.
TrastuzumabDrug
Also called Herceptin®
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.
PaclitaxelDrug
Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care).
Lumpectomy or Mastectomy with Sentinel Node or Axillary Node DissectionProcedure or surgery

Study groups in NCT01901146
Study group	Role	What they receive
ABP 980	Experimental	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. Receives: Drug: ABP 980; Drug: Paclitaxel; Procedure: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection
Trastuzumab	Active comparator	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. Receives: Drug: Trastuzumab; Drug: Paclitaxel; Procedure: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Pathologic Complete Response
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.
Measured: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase

Secondary outcomes (2)

Percentage of Participants With a Pathologic Complete Response in Breast Tissue Only
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.
Measured: 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
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.
Measured: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 201327 Jan 2017

First posted17 Jul 2013 (estimated)
Study start29 Apr 2013
Primary completion5 May 2016
Study completion27 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 725 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01901146
Sponsor's protocol ID: 20120283
Other IDs: 2012-004319-29
Acronym: Lilac
Status last verified: Feb 2018
First submitted: 20 May 2013
Last updated: 7 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kolberg HC, Colleoni M, Demetriou GS, Santi P, Tesch H, Fujiwara Y, Tomasevic Z, Hanes V. Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study. Drug Saf. 2020 Mar;43(3):233-242. doi: 10.1007/s40264-019-00886-3.
PubMed 31927716
von Minckwitz G, Colleoni M, Kolberg HC, Morales S, Santi P, Tomasevic Z, Zhang N, Hanes V. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):987-998. doi: 10.1016/S1470-2045(18)30241-9. Epub 2018 Jun 4.
PubMed 29880292

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01901146
Acronym / sponsor ID: Lilac / 20120283
Conditions: Breast Cancer
Keywords: Human Epidermal Growth Factor Receptor 2 (HER2), Positive Early Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 725 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Collaborators: Actavis Inc.
Study start: 29 Apr 2013 (actual)
Primary completion: 5 May 2016 (actual)
Study completion: 27 Jan 2017 (actual)
First posted: 17 Jul 2013 (estimated)
Results: Posted 7 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ABP 980	Experimental	Drug: ABP 980, Drug: Paclitaxel, Procedure: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node DissectionParticipants 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.
Trastuzumab	Active comparator	Drug: Trastuzumab, Drug: Paclitaxel, Procedure: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node DissectionParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABP 980ABP 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	ABP 980
TrastuzumabAlso: Herceptin®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.	Drug	Trastuzumab
PaclitaxelPaclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care).	Drug	ABP 980, Trastuzumab
Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection	Procedure or surgery	ABP 980, Trastuzumab

Primary outcome

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.

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 7 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABP 980	364	358
Trastuzumab	361	347
ABP 980/ABP 980	0	0
Trastuzumab/Trastuzumab	0	0
Trastuzumab/ABP 980	0	0

Primary outcome: 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. Number. Unit: percentage of participants

Measure	ABP 980 n = 358	Trastuzumab n = 338
Value	48.0	40.5

ABP 980 vs Trastuzumab: Risk Difference (RD): 7.3 (90% CI 1.2 to 13.4), p = 0.0508, Generalized linear model
ABP 980 vs Trastuzumab: Risk Ratio (RR): 1.1877 (90% CI 1.0327 to 1.3660), p = 0.0430, Generalized linear model

Population analysed: The pCR evaluable population, which included all randomized participants who received any amount of study drug, underwent the surgery, and had a non-missing evaluable pCR assessment from the local laboratory evaluation.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neoadjuvant Phase: ABP 980	18 of 364 (4.9%)	227 of 364 (62.4%)	Not reported
Neoadjuvant Phase: Trastuzumab	5 of 361 (1.4%)	220 of 361 (60.9%)	Not reported
Adjuvant Phase: ABP 980/ABP 980	18 of 349 (5.2%)	124 of 349 (35.5%)	Not reported
Adjuvant Phase: Trastuzumab/Trastuzumab	6 of 171 (3.5%)	49 of 171 (28.7%)	Not reported
Adjuvant Phase: Trastuzumab/ABP 980	6 of 171 (3.5%)	60 of 171 (35.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31927716Kolberg HC, Colleoni M, Demetriou GS, Santi P, Tesch H, Fujiwara Y, Tomasevic Z, Hanes V. Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study. Drug Saf. 2020 Mar;43(3):233-242. doi: 10.1007/s40264-019-00886-3.
Derived from this study: PubMed 29880292von Minckwitz G, Colleoni M, Kolberg HC, Morales S, Santi P, Tomasevic Z, Zhang N, Hanes V. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):987-998. doi: 10.1016/S1470-2045(18)30241-9. Epub 2018 Jun 4.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

98 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABP 980, Trastuzumab and Paclitaxel in people with Breast Cancer, run by Amgen at 98 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Russia, Poland, Ukraine, Italy, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01901146, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.