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

NCT01537536 | Completed Phase 2

• 1 other identifier: IJBNeoEndoTAG-1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer

Keywords

Breast cancer; Neoadjuvant chemotherapy; EndoTAG-1

Outcome Measures

Primary Outcomes (1)

• MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.

  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.

  15 weeks after start of neoadjuvant chemotherapy.

Secondary Outcomes (1)

• Rate of pathological complete response (pCR).

  27 weeks after start of neoadjuvant chemotherapy.

Study Arms (1)

EndoTAG-1

EXPERIMENTAL

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

Interventions

EndoTAG-1 DRUG

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.

Also known as: Non applicable

EndoTAG-1

Eligibility Criteria

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

You may qualify if:

• newly diagnosed histologically confirmed BC with breast infiltrating carcinoma of histological grade \> 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy
• HER2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (FISH)
• ECOG performance status 0 or 1
• 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 (females of childbearing potential)
• Signed informed consent

You may not qualify if:

• Metastatic or relapsed disease
• Major surgery \< 3 weeks prior to enrollment
• Severe pulmonary obstructive or restrictive disease
• Uncontrolled inflammatory disease (autoimmune or infectious)
• Clinically significant cardiac disease (NYHA stadium \> 2)
• 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
• Pregnancy or nursing status

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, Brussels Capital, 1000, Belgium

Location

Related Publications (1)

• Ignatiadis M, Zardavas D, Lemort M, Wilke C, Vanderbeeken MC, D'Hondt V, De Azambuja E, Gombos A, Lebrun F, Dal Lago L, Bustin F, Maetens M, Ameye L, Veys I, Michiels S, Paesmans M, Larsimont D, Sotiriou C, Nogaret JM, Piccart M, Awada A. Feasibility Study of EndoTAG-1, a Tumor Endothelial Targeting Agent, in Combination with Paclitaxel followed by FEC as Induction Therapy in HER2-Negative Breast Cancer. PLoS One. 2016 Jul 25;11(7):e0154009. doi: 10.1371/journal.pone.0154009. eCollection 2016.

  PMID: 27454930 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MBT-0206

Condition Hierarchy (Ancestors)

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

Study Officials

• Michail Ignatiadis, MD, PhD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

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, 2011
• First Posted: February 23, 2012
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 17, 2013

Record last verified: 2012-02

Locations

BE (1)