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Phase II Study of Cabazitaxel as 2nd Line Treatment in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Taxanes

Phase 2
18 Years
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase II Study of Cabazitaxel as 2nd Line Treatment in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Taxanes

Inclusion Criteria:

- Written informed consent

- Female patients aged 18 to 75 years

- Patients must have received 1st-line chemotherapy for locally recurrent / metastatic

- Prior taxane-containing treatment (paclitaxel, docetaxel or nab-paclitaxel), either
for advanced disease or as neoadjuvant/adjuvant chemotherapy. In case of early
relapse (relapse during neoadjuvant/adjuvant chemotherapy or disease-free interval
less than 6 months), neoadjuvant/adjuvant chemotherapy will be considered as 1st-line

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

- Eastern Cooperative Oncology Group performance status (PS) of 0-1

- Life expectancy of at least 12 weeks

- Measurable disease by the Response Criteria in Solid Tumors 1.1 (RECIST 1.1) method
(at least one measurable lesion)

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

1. Hemoglobin ≥ 9.0 g/dL

2. Absolute neutrophil count of ≥ 1.5 x 10^9/L

3. Thrombocyte count of ≥ 100 x 10^9/L

4. Serum creatinine ≤ 1.5 upper limit of normal (ULN). If creatinine 1.0 - 1.5 x
ULN, creatinine clearance will be calculated according to CKD-EPI formula and
patients with creatinine clearance <60 mL/min should be excluded

5. SGOT (AST), SGPT (ALT) ≤ 2.5 x ULN and alkaline phosphatase ≤ 2.5 x ULN, total
bilirubin ≤ ULN (the same limits also refer to patients with liver metastases)

- Previous treatment for loco-regional disease is allowed, including surgical
procedures or palliative radiotherapy (such treatments must have been completed at
least 4 weeks before enrolment)

- Compliance of the patient regarding scheduled visits, treatment plan, laboratory
tests and other procedures of the study.

- The enrolment of patients with controlled brain metastases is allowed (metastases
that have been treated with radiotherapy and remained stable for at least 4 weeks
following the completion of radiation treatment)

Exclusion Criteria:

- Patients that have received more than one lines of chemotherapy for locally
recurrent/metastatic disease

- Concurrent or planned treatment with strong inhibitors or strong inducers of
cytochrome P450 3A4/5 (a wash-out period of two weeks is necessary for patients who
are already on these treatments)

- Patients with CTC grade 2 or greater neuropathy at baseline

- Diagnosis of spinal cord compression or carcinomatous meningitis

- Uncontrolled severe illness or medical condition (including uncontrolled diabetes

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

- Any other significant acute or chronic medical or psychiatric condition or abnormal
laboratory finding which, according to the investigator's opinion, could result in
excessive danger, regarding the participation of the patient in the study.

- 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

- Concurrent administration of other investigational treatments and/or anti-neoplastic

- Pregnancy or lactation. Patients should be surgically sterile or post-menopausal or
they must agree to use adequate contraceptive methods during study period. For all
patients of childbearing potential a serum or urine pregnancy test is needed. The
definition of effective contraceptive methods will be based on the investigator's

- History of severe hypersensitivity reaction (≥grade 3) to docetaxel or polysorbate 80
containing drugs

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR).

Outcome Time Frame:

At an average of 24 months for each patient

Safety Issue:


Principal Investigator

Angelos Koutras, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Division of Oncology,Dept of Internal Medicine,University Hospital of Patras


Greece: National Organization of Medicines

Study ID:

HE 11B/11



Start Date:

September 2012

Completion Date:

September 2015

Related Keywords:

  • Breast Cancer
  • HER-2 negative
  • Metastatic breast adenocarcinoma
  • Breast Neoplasms