Text Size

Trial of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in HER2-negative Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01537536
First received: September 20, 2011
Last updated: June 6, 2012
Last verified: February 2012
History of Changes
  Purpose

The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of weekly paclitaxel. This is a prospective single-center study that will investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant chemotherapy).


Condition Intervention Phase
Breast Cancer
 Drug: EndoTAG-1
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in Patients With HER2-negative Breast Cancer

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:
  • MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline. [ Time Frame: 15 weeks after start of neoadjuvant chemotherapy. ] [ Designated as safety issue: No ]
    To investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative BC candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.


Secondary Outcome Measures:
  • Rate of pathological complete response (pCR). [ Time Frame: 27 weeks after start of neoadjuvant chemotherapy. ] [ Designated as safety issue: No ]
    Rate of pathological complete response (pCR) at the end of neo-adjuvant chemotherapy.


Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EndoTAG-1
Weekly treatment with EndoTAG-1 (22 mg/m2) plus paclitaxel (70 mg/m2) for 12 weeks (ET+P) followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery.
 Drug: EndoTAG-1
EndoTAG-1 (22 mg/m2 liposomal paclitaxel) + Paclitaxel (70 mg/m2) Weekly i.v. infusions of EndoTAG-1 and paclitaxel for 12 weeks followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery.
Other Name: Non applicable

Detailed Description:

This is a prospective, single-center, open-label phase II clinical trial investigating the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative BC candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour volume at the end of EndoTAG-1 + paclitaxel administration. Patients will be stratified by hormone receptor status.

A total of 20 female patients with non-metastatic HER2-negative breast cancer candidate for neoadjuvant chemotherapy and meeting all study eligibility criteria will receive 12 weekly infusions of EndoTAG-1 (22 mg/m2 liposomal paclitaxel) in combination with paclitaxel (70 mg/m2) followed by 3 cycles of FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) every 3 weeks (experimental group) The study hypothesis is that EndoTAG-1 will improve MRI- estimated volume reduction when added to weekly paclitaxel. The null hypothesis is that combination has no or a negligible effect on volume reduction (defined as lower or equal to a 50% decrease) versus the alternative hypothesis that the combination yields at least a 80% average decrease in MRI- estimated volume at the end of weekly paclitaxel and EndoTAG-1 administration from baseline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. newly diagnosed histologically confirmed BC with breast infiltrating carcinoma of histological grade > 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy
  2. HER2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (FISH)
  3. ECOG performance status 0 or 1
  4. Gender: female
  5. Age : >= 18 years old
  6. Negative pregnancy test (females of childbearing potential)
  7. Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential)
  8. Signed informed consent

Exclusion Criteria:

  1. Metastatic or relapsed disease
  2. Major surgery < 3 weeks prior to enrollment
  3. Severe pulmonary obstructive or restrictive disease
  4. Uncontrolled inflammatory disease (autoimmune or infectious)
  5. Clinically significant cardiac disease (NYHA stadium > 2)

  6. Results of laboratory tests (hematology, chemistry) outside specified limits:

    • WBC ≤ 3 x 109/L
    • ANC < 1.5 x 109/L
    • Platelets < 100 x 109/L
    • Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
    • PTT/ INR > 1.5 x ULN
    • AST or ALT > 2.5 x ULN
    • Alkaline Phosphatase > 2 x ULN
    • Total Bilirubin > 1.5 x ULN
  7. Pregnancy or nursing status
  8. Known positive HIV testing
  9. Known hypersensitivity to any component of the EndoTAG-1, paclitaxel or FEC formulations
  10. History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
  11. History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
  12. Concurrent treatment with other experimental products. Participation in another clinical trial with any investigational product within 30 days prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537536

Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Investigators
Principal Investigator: Michail Ignatiadis, MD, PhD Institut Jules Bordet
  More Information

No publications provided

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01537536     History of Changes
Other Study ID Numbers: IJBNeoEndoTAG-1
Study First Received: September 20, 2011
Last Updated: June 6, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Jules Bordet Institute:
Breast cancer
Neoadjuvant chemotherapy
EndoTAG-1

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013