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Phase 2 Trial of AEZS-108 in Chemotherapy Refractory in Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT01698281
Recruitment Status : Terminated (Poor recruitment)
First Posted : October 2, 2012
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Zoptarelin doxorubicin Drug: paclitaxel Drug: nab-paclitaxel Drug: eribulin Drug: pegylated liposomal doxorubicin Drug: vinorelbine Drug: gemcitabine Drug: capecitabine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Trial of AEZS-108 in Chemotherapy Refractory Triple Negative, LHRH-positive Metastatic Breast Cancer.
Study Start Date : December 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AEZS-108
AEZS-108 (267 mg/m2, 2-hour IV infusion every Day 1 of a 21-day (3-week) cycle
Drug: Zoptarelin doxorubicin
Active Comparator: Standard single agent cytotoxic chemotherapy
commercially available SSCC (doses below the recommended package insert at the discretion of treating oncologist), on a 21-day cycle (although weekly administration is allowed; note: pegylated liposomal doxorubicin will be administered on a 28-day cycle).
Drug: paclitaxel Drug: nab-paclitaxel Drug: eribulin Drug: pegylated liposomal doxorubicin Drug: vinorelbine Drug: gemcitabine Drug: capecitabine


Outcome Measures

Primary Outcome Measures :
  1. Efficacy of AEZS-108 compared to standard single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free survival. [ Time Frame: Up to two years ]

Secondary Outcome Measures :
  1. Efficacy of AEZS-108 [ Time Frame: Up to two years ]
  2. Overall response of AEZS-108 [ Time Frame: Up to two years ]
  3. Clinical benefit of AEZS-108 [ Time Frame: up to 2 years ]
  4. Duration of response of AEZS-108 [ Time Frame: up to 2 years ]
  5. Overall survival of AEZS-108 [ Time Frame: up to 2 years ]
  6. Toxicity of AEZS-108 [ Time Frame: up to 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Women ≥ 18 years of age
  2. Histologically documented breast cancer (either primary or metastatic site) that is (i) ER-negative (0), (ii) PR-negative (0), and (iii) HER2-negative, defined by IHC (immunohistochemistry; IHC 0/1, non-overexpressing) or FISH (fluorescence in situ hybridization; FISH negative) or CISH (chromogen in situ hybridization; CISH negative).
  3. Expression of LHRH receptor confirmed by IHC on archival (or current biopsy of breast tumor or metastatic site) breast cancer tissue
  4. Progressive disease after failure of 1 to 3 prior chemotherapy regimens for recurrent or metastatic (Stage IV) disease (prior adjuvant/neoadjuvant therapy is allowed)
  5. Measurable disease by RECIST 1.1 criteria; at least one target lesion that has not been previously irradiated.

Exclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status > 2
  2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or recent myocardial infarction (within 6 months of enrollment)
  3. Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention
  4. Left ventricular ejection fraction (LVEF) < 50 %, determined by echocardiogram or MUGA scan
  5. Compromised organ or marrow function as evidenced by any of the following:

    • thrombocyte count: < 100x109/L
    • absolute neutrophil count (ANC): < 1.5x109/L
    • hemoglobin: < 6.0 mmol/L (< 9 g/100 mL)
    • AS(A)T, AL(A)T: > 2.5 times upper limit of normal range (ULN) (> 5x ULN if clearly related to liver metastases)
    • bilirubin: > 1.5 mg/dL
    • creatinine: > 1.5 mg/dL or creatinine clearance < 40 mL/min.
  6. Systemic anticancer therapy or radiotherapy within 21 calendar days of the first dose of study drug*)

    * also excluded are patients with anticipated ongoing concomitant anticancer therapy during the study

  7. Prior exposure to anthracyclines or anthracenediones for the treatment of metastatic breast cancer including liposomal doxorubicin (Doxil), doxorubicin, daunorubicin, or mitoxantrone
  8. Prior adjuvant anthracyclines with a cumulative anthracycline dose ≥ 300 mg/m2
  9. Ongoing therapeutic anticoagulation
  10. Patients who are not surgically sterile or post-menopausal must agree to use for the duration of the study reliable methods of birth control defined as:

    • complete abstinence
    • any intrauterine device (IUD) with published data showing that the lowest expected failure rate is < 1 % per year, or
    • any other methods with published data showing that the lowest expected failure rate is less than 1 % per year
  11. Investigational therapy within 30 calendar days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).
Contacts and Locations

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): NCT01698281


Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Germany
Universitäts-Frauenklinik
Göttingen, Germany
Klinik für Frauenheilkunde und Geburtshilfe
Regensburg, Germany
Sponsors and Collaborators
AEterna Zentaris
Investigators
Principal Investigator: Alberto J. Montero, MD University of Miami
More Information

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01698281     History of Changes
Other Study ID Numbers: AEZS-108-049
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: May 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Vinorelbine
Gemcitabine
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Capecitabine
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors