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Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Subjects With HER2 Positive Early Breast Cancer (Lilac)

This study has been completed.
Sponsor:
Collaborator:
Actavis Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01901146
First received: May 20, 2013
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with early breast cancer.

Condition Intervention Phase
Breast Cancer Drug: ABP 980 Drug: trastuzumab Drug: epirubicin Drug: cyclophosphamide Drug: paclitaxel Procedure: Lumpectomy or mastectomy with sentinel node or axillary node dissection Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 827
Actual Study Start Date: April 29, 2013
Study Completion Date: January 27, 2017
Primary Completion Date: May 5, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABP 980
Epirubicin and cyclophosphamide followed by ABP 980 plus paclitaxel. Surgery (breast and sentinel node or axillary lymph node resection) will be completed within 3 to 7 weeks after the last dose of investigational product in the neoadjuvant phase.
Drug: ABP 980 Drug: epirubicin Drug: cyclophosphamide Drug: paclitaxel Procedure: Lumpectomy or mastectomy with sentinel node or axillary node dissection
Active Comparator: trastuzumab

Epirubicin and cyclophosphamide followed by trastuzumab plus paclitaxel.

Surgery (breast and sentinel node or axillary lymph node resection) will be completed within 3 to 7 weeks after the last dose of investigational product in the neoadjuvant phase.

Drug: trastuzumab Drug: epirubicin Drug: cyclophosphamide Drug: paclitaxel Procedure: Lumpectomy or mastectomy with sentinel node or axillary node dissection

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901146

  Show 99 Study Locations
Sponsors and Collaborators
Amgen
Actavis Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01901146     History of Changes
Other Study ID Numbers: 20120283
2012-004319-29 ( EudraCT Number )
Study First Received: May 20, 2013
Last Updated: April 6, 2017

Keywords provided by Amgen:
Human Epidermal Growth Factor Receptor 2 (HER2)
Positive Early Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Trastuzumab
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 22, 2017