An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- MediGene
- Enrollment
- 143
- Locations
- 33
- Primary Endpoint
- 4-month progression free survival (PFS) rate
Overview
Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of a therapy with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for patients with relapsed or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer).
Detailed Description
Breast cancer is still a major public health problem worldwide, as it is by far the most frequent neoplasm in women. In recent years so-called "profiling of breast cancer" with expression arrays has become common and it was suggested that the results will allow individualization of care. Breast cancer may now be subclassified into luminal, basal, and HER-2 subtypes with distinct differences in prognosis and response to therapy. About 80% of all basal-like-breast cancers possess a so-called "triple-receptor-negative" phenotype.
Patients with "triple receptor negative breast cancer" have a complete absence of hormone receptors incl. HER-2, an aggressive clinical course and a paucity of treatment options. The only therapeutic option is chemotherapy and in this respect the choice of cytostatic agents is limited. Against this background, the study tries to find another therapeutic option by combining a vascular-disrupting activity with the cytostatic effects of paclitaxel in the study drug EndoTAG-1.
Comparison: EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) in comparison to paclitaxel (control group)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically proven triple-receptor-negative metastatic or relapsed breast cancer
- •Minimum interval of 6 months after the end of any previous taxane- containing chemotherapy regimen
- •At least one tumor lesion measurable according to RECIST criteria
- •Gender: female
- •Age \>= 18 years old
- •Negative pregnancy test (females of childbearing potential)
- •Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment
- •ECOG performance status 0, 1 or 2
- •Signed informed consent
Exclusion Criteria
- •More than 1 previous chemotherapeutic treatment for metastatic or relapsed disease
- •Major surgery \< 4 weeks prior to enrollment
- •Immunotherapy \< 2 weeks prior to enrollment
- •Severe pulmonary obstructive or restrictive disease
- •Uncontrolled inflammatory disease (autoimmune or infectious)
- •Clinically significant cardiac disease (NYHA stadium \> 2)
- •Laboratory tests (hematology, chemistry) outside specified limits
- •Pregnancy or nursing status
- •Known positive HIV testing
- •Known hypersensitivity to any component of the EndoTAG-1 or taxane formulations
Arms & Interventions
1
EndoTAG-1 + Paclitaxel
Intervention: EndoTAG-1 + paclitaxel (Drug)
2
EndoTAG-1
Intervention: EndoTAG-1 (Drug)
3
Paclitaxel
Intervention: Paclitaxel (Drug)
Outcomes
Primary Outcomes
4-month progression free survival (PFS) rate
Time Frame: 4 month
Secondary Outcomes
- laboratory values(Last patient out)
- dose variations(Last patient out)
- adverse events(Last patient out)
- median progression free survival (PFS) time(progression of last patient)
- tumor response(Last patient out)
- 4-month survival rate(4-month)
- median overall survival time(Withdrawal or death of last patient)
- pain assessment(Last patient out)
- clinical benefit assessment via quality of life (QoL)Scale(Last patient out)