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Trial record 99 of 173 for:    pertuzumab

The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane. (REVER)

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ClinicalTrials.gov Identifier: NCT03619044
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 7, 2018
Last Update Posted Date December 4, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
The rate of patients with conversion of FES negative lesions in FES positive lesions. [ Time Frame: Cycle 3 Day 1 for each patient. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03619044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • The rate of patients with FES positive lesions before treatment. [ Time Frame: Cycle 4 Day 1 for each patient. ]
  • The adverse events due to FES-PET imaging evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. [ Time Frame: Cycle 4 Day 1 for each patient. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.
Official Title  ICMJE The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.
Brief Summary

This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.

For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).

Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.

Patients will be followed during the 3 cycles of treatment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE HER2-positive Breast Cancer
Intervention  ICMJE Other: 2 FES-PET Imaging will be performed:
  • before treatment initiation
  • before treatment cycle 3 initiation
Study Arms  ICMJE Patients with metastatic breast cancer
Patients with metastatic breast cancer treated with trastuzumab + pertuzumab + taxane in the metastatic first line.
Intervention: Other: 2 FES-PET Imaging will be performed:
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
33
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
  3. Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
  4. Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
  5. OMS ≤ 2.
  6. For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
  7. Patient affiliated to a Social Health Insurance in France.
  8. Patient must provide written informed consent prior to any study specific procedures.

Exclusion Criteria:

  1. Any previous treatment for metastatic disease.
  2. Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
  3. Patient with isolated hepatic metastasis.
  4. Patient with hemostasis disorders.
  5. Unbalanced Diabetes.
  6. Patient with usual formal contraindication to PET/TDM Imaging.
  7. Patient who has already started trastuzumab + pertuzumab + taxane treatment.
  8. Pregnant or breastfeeding women.
  9. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
  10. Patient protected by law.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Florence DALENC, MD-PhD 5 31 15 51 04 dalenc.florence@iuct-oncopole.fr
Contact: Frédéric COURBON, MD-PhD 05 31 15 56 27 courbon.frederic@iuct-oncopole.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03619044
Other Study ID Numbers  ICMJE 18 SEIN 08
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Claudius Regaud
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP