Study of Cabazitaxel in Patients With Metastatic Breast Cancer Previously Treated With Taxanes

NCT01693549 | Completed Phase 2

• 2 other identifiers: HE 11B/112011-003625-97
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this study is to determine whether cabazitaxel is effective in the treatment of metastatic breast cancer.

Conditions

Breast Cancer

Keywords

HER-2 negative; Metastatic breast adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR).

  At an average of 24 months for each patient

Secondary Outcomes (5)

• Duration of response.

  From the time measurement criteria are first met for partial or complete response until the first date of documented progressive disease or death from any cause without prior documentation of progression assessed up to 30 months.

• Evaluation of progression-free survival (PFS)

  From study entry until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression, assessed up to 30 months.

• Evaluation of overall survival (OS)

  Defined as the time in months from study entry until the time of death, assessed up to 30 months.

• Assessment of safety and tolerability.

  Evaluation of Adverse Events will be performed every 21 days (per cycle) during treatment assessed up to 30 months.

• Value of prognostic and/or predictive biomarkers measured in tissue and blood samples

  Tumor blocks and blood DNA will be collected at study entry and plasma at study entry, on week 3 and week 6 of treatment.

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

Cabazitaxel(XRP6258) will be administered on day 1 of each cycle, every 21 days, at a dose of 25 mg/m² by i.v. route in 1 hour. Treatment can be continued until patient's consent withdrawal, intolerable toxicity or documented disease progression.

Drug: Cabazitaxel

Interventions

Cabazitaxel DRUG

Also known as: Jevtana, XRP6258

Cabazitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Female patients aged 18 to 75 years
• Patients must have received 1st-line chemotherapy for locally recurrent / metastatic disease
• 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 treatment
• 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:
• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count of ≥ 1.5 x 10\^9/L
• Thrombocyte count of ≥ 100 x 10\^9/L
• 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
• 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)

You may not qualify if:

• 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 mellitus)
• 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 agents
• 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 opinion.
• History of severe hypersensitivity reaction (≥grade 3) to docetaxel or polysorbate 80 containing drugs

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead
• Sanofi: collaborator

Study Sites (17)

Dept of Medical Oncology, 251 General Air Force Hospital

Athens, 11525, Greece

Location

2nd Dept of Medical Oncology, General Hospital of Athens "Hippokratio"

Athens, 11527, Greece

Location

Oncology section, Dept of Clinical Therapeutics, General Hospital of Athens "Alexandra"

Athens, 11528, Greece

Location

Division of Oncology, 2nd Dept of Internal Medicine, Propaedeutic, University Hospital "Attikon"

Athens, 12462, Greece

Location

2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

Athens, 14564, Greece

Location

3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

Athens, 14564, Greece

Location

3rd Dept of Medical Oncology, Hygeia Hospital

Athens, 15123, Greece

Location

1st Dept of Medical Oncology, Metropolitan Hospital

Athens, 18547, Greece

Location

2nd Dept of Medical Oncology, Metropolitan Hospital

Athens, 18547, Greece

Location

2nd Dept of Medical Oncology, Agios Savvas Cancer Hospital

Athens, Greece

Location

Oncology Dept., General Hospital of Chania "Agios Georgios"

Chania, 73300, Greece

Location

Dept of Medical Oncology, University Hospital of Heraklion

Heraklio, 71110, Greece

Location

Dept of Medical Oncology, Ioannina University Hospital

Ioannina, 45110, Greece

Location

General Hospital of Patra "Agios Andreas"

Pátrai, 26335, Greece

Location

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

Rio, Patras, 26504, Greece

Location

Dept of Medical Oncology, Papageorgiou General Hospital

Thessaloniki, 56429, Greece

Location

Dept of Medical Oncology, Thermi Clinic S.A

Thessaloniki, 57001, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

cabazitaxel; XRP6258

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Angelos Koutras, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: July 10, 2017
• Study Completion: July 20, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

GR (17)