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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02338531
Recruitment Status : Withdrawn (Due to the discontinuation of the development of the Notch inhibitor PF-03084014-04)
First Posted : January 14, 2015
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: PF-03084014 Procedure: Breast cancer surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarker Research Study for PF-03084014 in cHEmoresistant Triple-negative Breast cAncer
Study Start Date : June 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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)
Drug: PF-03084014
Procedure: Breast cancer surgery



Primary Outcome Measures :
  1. HES4 gene expression level [ Time Frame: tumour tissue samples before study drug and after 9 days of study drug. General analysis after all patients included. ]
    To demonstrate that PF-03084014 is able to modulate the Notch pathway by down-regulating the expression of the tumor HES4 gene in chemoresistant TNBC (evaluable population).


Secondary Outcome Measures :
  1. Safety: General assesment of number and grade of adverse events after short(9-day) administration of oral PF-03084014 in patients with chemoresistant TNBC. [ Time Frame: adverse events followed up to 28 days after last PF-03084014 dose. ]
    Patients will be followed for Adverse Events and Serious Adverse Events from the first dose of study drug up to 28 days after the last dose.

  2. Transcriptome analysis (changes in the HES4 gene expression and tumor transcriptome) [ Time Frame: tissue samples before study drug and after 9 days of study drug. General analysis after all patients included. ]
    To assess changes in the HES4 gene expression and tumor transcriptome for all patients registered in the RHEA study (intent-to-treat population)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338531


Locations
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Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Grand Hopital de Charleroi
Charleroi, Belgium, 6000
CMSE
Namur, Belgium, 5000
France
Institut Curie
Paris, France, 750005
Institut de Cancérologie Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Jules Bordet Institute
Investigators
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Study Director: Michail Ignatiadis, MD, PhD Medical Oncology Department

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Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT02338531    
Other Study ID Numbers: IJB-TNBC-1-RHEA
2014-004358-32 ( EudraCT Number )
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases