Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04198727
Other study ID # 2017/15
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 20, 2020
Est. completion date April 2026

Study information

Verified date November 2023
Source Centre Antoine Lacassagne
Contact Christine LOVERA
Phone +33 492031618
Email christine.lovera@nice.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the Impact of DihydroPyrimidine Dehydrogenase (DPD) activity on the efficacy of Capecitabine in patients with metastatic breast cancer. The DPD phenotype before the initiation of treatment will be assess and then the patient will be follow up during the treatment with Capecitabine up to 24 month.


Recruitment information / eligibility

Status Recruiting
Enrollment 155
Est. completion date April 2026
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age over 18, - Performance status 0 to 2, - Patients with metastatic HER2 negative breast cancer, - Patients eligible for capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days, - Determination of Uracil level performed according to national recommendations, - Patients with at least one lesion evaluable according to the RECIST criteria 1.1, or presenting at least 1 hypermetabolic lesion on PET-TDM according to PERCIST 1.0 criteria. In the case of single cutaneous metastasis (s), it is required to make photographs of lesions with a measure of the lesions using a ruler, - Patients receiving social coverage. Exclusion Criteria: - Performance status> 2, - Contraindication to capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days, - Presence of untreated or uncontrolled symptomatic cerebral or leptomeningeal metastases (unstable corticosteroid requirements) and / or non-clinically stable in the 3 months prior to inclusion, - History of cancer, with the exception of cancers in complete remission for more than 5 years, totally resected cutaneous basal cell carcinoma, in situ carcinoma or in situ cervical epithelioma treated, - Vulnerable people

Study Design


Intervention

Other:
DPD activity assessment
Phenotyping DPD with enzyme activity measure and uracil dosage
Drug:
Capecitabine
Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of

Locations

Country Name City State
France Clinique Saint Jean Cagnes-sur-Mer
France Centre Azuréen de Cancérologie Mougins
France Centre Antoine Lacassagne Nice
France Clinique St Georges Nice
Monaco Hôpital Princesse Grâce Monaco

Sponsors (2)

Lead Sponsor Collaborator
Centre Antoine Lacassagne Cerbaliance

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 months objective response rate The primary endpoint will be the 6-month objective response to treatment measured using the RECIST 1.1 scale, or PERCIST 1.0. The objective response is defined as the aggregation of the complete + partial response against stabilization + progression.
The distribution of the objective response rate with respect to the value of individual lymphocyte DPD activity before treatment will be examined. This analysis will consist in comparing the objective response rate between patients with a proficient DPD phenotype, measured by lymphocyte DPD activity (> at the 3rd quartile, ie 25% of the initial population) and non-deficient patients with DPD (including phenotype). between the 13th and 75th percentiles of the initial population).
6 months
Secondary 6 months objective response in proficient DPD phenotype RECIST 1.1 or PERCIST 1.0 criteria 6 months
Secondary Correlation between the level of lymphocyte DPD activity and uracil dosage 1 month
Secondary Progression-free survival 24 months
Secondary Capecitabine Toxicity using CTCAE v 5.0 24 months
See also
  Status Clinical Trial Phase
Recruiting NCT05941299 - Clinical Trial to Demonstrate the Safety and Performance of REGENERA Breast Implant in 40-70 Years Old Women Affected by Malignant Breast Lesion Treated by Lumpectomy N/A
Completed NCT04348955 - Interest of Touch-massage in Hospital Day Care
Completed NCT05812326 - PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer Phase 1/Phase 2
Recruiting NCT04424732 - SBRT for Breast Cancer Oligometastases N/A
Completed NCT03109080 - Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC) Phase 1
Completed NCT03525990 - Study Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients N/A
Recruiting NCT04289805 - Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE) Phase 4
Available NCT05134922 - Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009