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Trial record 1 of 32 for:    ABP-980
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Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer (Lilac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 20, 2013
First Posted Date  ICMJE July 17, 2013
Results First Submitted Date  ICMJE June 18, 2019
Results First Posted Date  ICMJE August 7, 2019
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE April 29, 2013
Actual Primary Completion Date May 5, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
Determination of pathologic complete response (pCR), defined by the absence of invasive tumor [ Time Frame: Within 3 to 7 weeks after the last dose of investigational product in the neoadjuvant phase ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
  • Event-free survival [ Time Frame: 16 months ]
    Assessment following adjuvant therapy with either ABP 980 or trastuzumab
  • Overall survival [ Time Frame: 16 months ]
    Assessment following adjuvant therapy with either ABP 980 or trastuzumab
  • Change in left ventricular ejection fraction (LVEF) [ Time Frame: 16 months ]
    Assessment following adjuvant therapy with either ABP 980 or trastuzumab
  • Subject incidence of adverse events [ Time Frame: 16 months ]
    Assessment following adjuvant therapy with either ABP 980 or trastuzumab
  • Incidence of anti-drug antibody and neutralizing antibody formation [ Time Frame: 16 months ]
    Assessment following adjuvant therapy with either ABP 980 or trastuzumab
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: ABP 980
    • Drug: Paclitaxel
    • 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.

    Interventions:
    • Drug: Trastuzumab
    • Drug: Paclitaxel
    • Procedure: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2019)
725
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2013)
588
Actual Study Completion Date  ICMJE January 27, 2017
Actual Primary Completion Date May 5, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Brazil,   Bulgaria,   Canada,   Chile,   Germany,   Greece,   Hungary,   Italy,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Ukraine,   United Kingdom
Removed Location Countries Slovakia
 
Administrative Information
NCT Number  ICMJE NCT01901146
Other Study ID Numbers  ICMJE 20120283
2012-004319-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Actavis Inc.
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP