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A Randomized Phase 2 Trial of AEZS-108 in Chemotherapy Refractory Triple Negative, LHRH-positive Metastatic Breast Cancer.


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Randomized Phase 2 Trial of AEZS-108 in Chemotherapy Refractory Triple Negative, LHRH-positive Metastatic Breast Cancer.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of AEZS-108 compared to standard single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free survival.

Outcome Time Frame:

Up to two years

Safety Issue:

No

Principal Investigator

Alberto J. Montero, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami

Authority:

United States: Food and Drug Administration

Study ID:

AEZS-108-049

NCT ID:

NCT01698281

Start Date:

December 2012

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

University of MiamiMiami, Florida  33136