Biomarker Research Study for PF-03084014 in cHEmoresistant Triple-negative Breast cAncer

NCT ID: NCT02338531

Last Updated: 2016-04-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-12-31

Brief Summary

This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic triple-negative breast cancer patients with residual disease (cHEmoresistant) after completion of standard neoadjuvant chemotherapy.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapeutic regimen

oral administration of PF-03084014, 9 days at 150 mg q.d. (day 1 and 9) and 150 b.i.d. (day 2 till 8)

Group Type: EXPERIMENTAL

PF-03084014

Intervention Type: DRUG

Breast cancer surgery

Intervention Type: PROCEDURE

Interventions

PF-03084014

Intervention Type: DRUG

Breast cancer surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old.

2. Female.

3. Histological diagnosis of triple-negative breast cancer (TNBC) breast adenocarcinoma (ER<1%, PR<1% by (IHC) and HER-2 0-1+ by IHC or IHC 2+ and FISH or CISH negative per updated ASCO guidelines).

4. No clinical or radiologic evidence of distant metastasis.

5. Presence of residual primary disease of at least 1.5 cm by U/S or MRI within 14 days preceding the last cycle of standard anthracycline and taxane-based neoadjuvant chemotherapy.

Patients with synchronous synchronous bilateral cancer and unilateral multifocal or multicentric or bilateral disease breast cancer will be allowed provided histologic diagnosis of TNBC is found on all performed biopsies.

6. Completion of standard anthracycline and taxane-based neoadjuvant chemotherapy. The use of platinum agents in combination with standard neoadjuvant chemotherapy is allowed.

7. ECOG Performance Status (PS) 0 or 1

8. Adequate Bone Marrow Function: Absolute Neutrophil Count (ANC) ≥ 1500/μL or ≥1.5 x 109/L; Platelets ≥100000/μL or ≥100 x 109/L; Hemoglobin ≥ 9 g/dL.

9. Adequate Renal Function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min.

10. Adequate Liver Function:Total serum bilirubin ≤ 1.0 x ULN or ≤ 2 x ULN in cases of known Gilberts syndrome; Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN.

11. For patients of childbearing potential: negative serum/urine pregnancy test and use accepted forms of non-hormonal contraception during the study period and up to 6 months after treatment completion.

Exclusion Criteria

1. Concurrent anti-cancer therapy for current breast cancer (hormone therapy, chemotherapy, radiotherapy, immunotherapy). Patients already included in another therapeutic trial involving an experimental drug.

2. Pregnant or lactating women.

3. Any prior history of invasive breast cancer.

4. Any previous history of non-breast malignancies (excepted basal cell carcinoma or squamous cell carcinoma of the skin) in the preceding 5 years.

5. Known hypersensitivity to the study drug or excipients.

6. Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study.

7. Subjects unable to swallow oral medications.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michail Ignatiadis, MD, PhD

Role: STUDY_DIRECTOR

Medical Oncology Department

Locations

Institut Jules Bordet

Brussels, , Belgium

Grand Hopital de Charleroi

Charleroi, , Belgium

CMSE

Namur, , Belgium

Institut Curie

Paris, , France

Institut de Cancérologie Gustave Roussy

Villejuif, , France

Countries

Belgium; France

Other Identifiers

2014-004358-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IJB-TNBC-1-RHEA

Identifier Type: -

Identifier Source: org_study_id