Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00790894
• Date of registration: 13/11/2008
• Prospective Registration: No
• Primary sponsor: Hellenic Cooperative Oncology Group
• Public title: Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT) HIT
• Scientific title: Phase II Randomized Trial of Ixabepilone Administered Weekly or Every Three Weeks in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Chemotherapy in the Neo-adjuvant or Adjuvant Setting
• Date of first enrolment: November 2008
• Target sample size: 64
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00790894
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Greece

Contacts

• Name: George Fountzilas
• Affiliation: Papageorgiou General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent

- Female patients aged 18 to 75 years inclusive

- Prior chemotherapy in the adjuvant or neo-adjuvant setting

- Diagnosis of HER-2 negative (HER-2 <2+ by immunohistochemistry and/or FISH negative)
metastatic breast adenocarcinoma confirmed by the pathology department of the
enrolling institution

- Eastern Cooperative Oncology Group performance status of 0 or 1

- Life expectancy of at least 12 weeks

- Measurable disease by the Response Criteria in Solid Tumors (RECIST) method

- Laboratory values within the specified ranges within 1 week of study enrolment:

- Absolute neutrophil count of = 1.5 x 109/L

- Thrombocyte count of = 100 x 109/L

- Subjects must not have received cytotoxic chemotherapy for locally
recurrent/metastatic disease

- Prior hormonal therapy for locally recurrent or metastatic disease allowed

- AST and ALT = 2.5 x ULN

- Bilirubin = 1.5 x ULN

- Recovery from prior palliative radiotherapy for bone metastases

Exclusion Criteria:

- Because of concerns that ixabepilone metabolism may be inhibited by potent cytochrome
P450 3A4 inhibitors, patients must not receive the following medications, up to 72
hours prior to initiation of study therapy and until they come off treatment with
ixabepilone: amprenavir, delavirdine, voriconazole, erythromycin, cyclosporine,
troleandomycin, terfenadine, ketoconazole, nelfinavir, and ritonavir

- Patients with CTC grade 2 or greater neuropathy at baseline

- Patients with any history or evidence of brain an/or leptomenigneal metastasis

- Patients with clinically significant cardiac disease (e.g. unstable angina,
congestive heart failure, myocardial infarction) within 6 months from study entry

- Psychiatric disorders or other conditions rendering the subject incapable of
complying with the requirements of the protocol

- Any concurrent active malignancy other than non-melanoma skin cancer or in situ
carcinoma of the cervix (subjects with a history of previous malignancies but without
evidence of disease for 5 years will be allowed to enter the trial)

- Prior severe HSR to agents containing Cremophor EL

- Women of childbearing potential (WOCBP) who are unwilling or unable to use an
adequate method of contraception to avoid pregnancy throughout the study and for up
to 12 weeks from the last dose of ixabepilone, in such a manner that the risk of
pregnancy is minimized WOCBP include: any female who has experienced menarche and who
has not undergone successful surgical sterilization (hysterectomy, bilateral tubal
ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea =
12 consecutive months; women on hormone replacement therapy with documented FSH level
> 35mIU/mL. Even women who are practising abstinence or whom their partner is sterile
(e.g. vasectomy) should be considered of childbearing potential.

- Women who are pregnant or breastfeeding

- Women with a positive pregnancy test on enrolment or prior to study therapy

- No other concomitant chemotherapy, endocrine therapy, immunotherapy, radiation
therapy (except for palliative radiotherapy for bone metastases) or investigational
treatments are allowed during subject's participation in the study



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: ixabepilone

Primary Outcome(s)

The primary endpoint of the study is the best Overall Response (OR). [Time Frame: At 6, 12 and 24 weeks]

Secondary Outcome(s)

Translational endpoints [Time Frame: Duration of the study]

Efficacy endpoints: time to response, PFS, TTF, duration of response [Time Frame: Duration of the study]

OS Toxicity endpoints: incidence of hematological and non-hematological toxicities [Time Frame: Duration of the study]

Secondary ID(s)

HE 11A08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors