Breast Neoplasm Malignant FemalePhase 2DPDMAXNCT04198727
Study of the Impact of DPD Activity on the Efficacy of Capecitabine
A Phase 2 study testing DPD activity assessment and Capecitabine in people with Breast Neoplasm Malignant Female, run by Centre Antoine Lacassagne at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Malignant Female
- What is being tested?
- DPD activity assessment and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Jul 2020to Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Clinique Saint Jean
Cagnes-sur-Mer, 06800
Centre Azuréen de Cancérologie
Mougins, 06250
Clinique St Georges
Nice, 06105
Centre Antoine Lacassagne
Nice, 06189
About this study
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.
- Conditions
- Breast Neoplasm Malignant Female
- Being tested
- DPD activity assessment, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPD activity assessmentOther
Also called Phenotyping
Phenotyping DPD with enzyme activity measure and uracil dosage
CapecitabineDrug
Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of
| Study group | Role | What they receive |
|---|---|---|
| DPD activity | Experimental | Not described Receives: Other: DPD activity assessment; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (4)
6 months objective response in proficient DPD phenotype
RECIST 1.1 or PERCIST 1.0 criteria
Measured: 6 months
Correlation between the level of lymphocyte DPD activity and uracil dosage
Measured: 1 month
Progression-free survival
Measured: 24 months
Capecitabine Toxicity using CTCAE v 5.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start20 Jul 2020
- Primary completionSep 2026 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm Malignant FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label multi-center prospective cohort study to compare the response of patients with high phenotype to patients with normal phenotype. The analyzes performed will focus on clinical and biological criteria.
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Collaborators
- Cerbaliance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198727
- Sponsor's protocol ID
- 2017/15
- Acronym
- DPDMAX
- Status last verified
- May 2026
- First submitted
- 10 Dec 2019
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of DPD Activity on the Efficacy of Capecitabine
- ClinicalTrials.gov ID
- NCT04198727
- Acronym / sponsor ID
- DPDMAX / 2017/15
- Conditions
- Breast Neoplasm Malignant Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Collaborators
- Cerbaliance
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label multi-center prospective cohort study to compare the response of patients with high phenotype to patients with normal phenotype. The analyzes performed will focus on clinical and biological criteria.
| Arm | Type | Receives |
|---|---|---|
| DPD activity | Experimental | Other: DPD activity assessment, Drug: Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPD activity assessmentAlso: PhenotypingPhenotyping DPD with enzyme activity measure and uracil dosage | Other | DPD activity |
| CapecitabineCapecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of | Drug | DPD activity |
Primary outcome
6 months objective response rate
Time frame: 6 months
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).
4 secondary outcomes
6 months objective response in proficient DPD phenotype
Time frame: 6 months
Correlation between the level of lymphocyte DPD activity and uracil dosage
Time frame: 1 month
Progression-free survival
Time frame: 24 months
Capecitabine Toxicity using CTCAE v 5.0
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DPD activity assessment and Capecitabine in people with Breast Neoplasm Malignant Female, run by Centre Antoine Lacassagne at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 months objective response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.