Metastatic Breast CancerPhase 1MODEL1NCT02392845
A Pilot Dose Escalation Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study
A Phase 1 study testing Combination of Docetaxel (DTX) and Epirubicin (EPI) in people with Metastatic Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
To determine the maximum tolerated dose of a densified regimen of the association of docetaxel (DTX) and epirubicin (EPI), supported by the concomitant administration of hematopoietic growth factors in patients with metastatic breast cancer in first-line, optimizing in each patient the administration schedule using a… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Combination of Docetaxel (DTX) and Epirubicin (EPI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 ≥ 18 years,
- ECOG performance status ≤ 2
- Diagnosed with metastatic HER2-negative hormone-resistant chemotherapy-naive breast cancers, previous adjuvant chemotherapy treatment are allowed.
- Histologically or cytologically proven breast cancer metastases or associated with CA 15-3 levels 50% above the normal value
- Hormone resistance defined by the presence of negative hormone receptors or disease progression within 6 months of the initiation of hormone therapy.
- Adequate renal and liver function (ASAT and ALAT < twice the upper limit normal value (ULN) if no liver metastases, or < 4×ULN if liver metastases; total bilirubin < 2×ULN),
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- Adequate cardiac function (left ventricular ejection fraction (LVEF) > 50%),
- Neutrophils ≥ 1200/mm3
- Platelets ≥ 105/mm3
Who cannot join
- Cerebral metastases and meningeal involvement,
- Other malignant diseases,
- Significant comorbidities,
- Previous chemotherapy for metastatic disease, or previous chemotherapy with a total cumulative dose greater than 600 mg/m² for EPI or greater than 450 mg/m² for DTX
Trial locations and contacts
1 site in 1 country.
France1 site
Gilles FREYER , Professor 04 78 86 43 18 Ext. +33 gilles.freyer@chu-lyon.fr
Lyon, 69002
About this study
Official title: A Pilot Dose Escalation Phase I Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study
To determine the maximum tolerated dose of a densified regimen of the association of docetaxel (DTX) and epirubicin (EPI), supported by the concomitant administration of hematopoietic growth factors in patients with metastatic breast cancer in first-line, optimizing in each patient the administration schedule using a formal procedure based on mathematical models in order to manage the severity of induced neutropenia.
The models used in this project allow:
Read more
- an optimal administration schedule of the planned total dose per cycle (number of infusions and calculating their rates and durations)
- an individualization of the administration schedule from the second cycle (based on observations from the first cycle), and
- an assessment of the risk of a dose-limiting toxicity event combining several severe non-hematological toxicities (conditioning the decision for dose escalation).
Using formal mathematical models the investigators expect controlling the hematological and non-hematological toxicities in order to realize the full series of six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient. For each patient, chemotherapy is considered feasible if it is possible, in the absence of tumor progression, to consider 6 cycles of treatment without observing any serious adverse events and without:
- patient death that may be related to the treatments;
- decision of the patient to interrupt treatment for physical or psychological tolerance reasons;
- decision of the investigator to discontinue treatment, in the absence of disease progression.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Combination of Docetaxel (DTX) and Epirubicin (EPI)
- Keywords
- Drug combination, Accelerated chemotherapy, Mathematical model, Hematotoxicity, Individualized dosage
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Docetaxel (DTX) and Epirubicin (EPI)Drug
Six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient
| Study group | Role | What they receive |
|---|---|---|
| Combination of Docetaxel (DTX) and Epirubicin (EPI) | Experimental | Not described Receives: Drug: Combination of Docetaxel (DTX) and Epirubicin (EPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the risk of Dose-limiting Toxicities
DLTs were defined as ≥ grade 3 vomiting, ≥ grade 3 mucositis,≥ grade 3 hand-foot syndrome (HFS), grade 2 vomiting plus grade 2 mucositis, or grade 2 vomiting plus grade 2 HFS
Measured: 84 days (6 treatment cycles x 14 days)
Secondary outcomes (4)
Plasma concentration of Docetaxel and Epirubicin after administration
Assessment of the pharmacokinetics of Docetaxel and Epirubicin
Measured: 84 days (6 treatment cycles x 14 days)
Tumor response for each patient with one or more measurable lesions
Measurement of tumor response by MRI for each patient with one or more measurable lesions, classified according to RECIST criteria
Measured: after 28 days (2 treatment cycles x 14 days) and 84 days (6 treatment cycles x 14 days)
Progression-free survival
Measured: 115 days (study duration (6 treatment cycles x 14 days) + follow-up (31 days) when available)
Overall survival
Measured: 115 days (study duration (6 treatment cycles x 14 days) + follow-up (31 days) when available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJun 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles FREYER, Professor, Principal investigator, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud - Service d'oncologie médicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392845
- Sponsor's protocol ID
- 2004.356
- Acronym
- MODEL1
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2015
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Dose Escalation Phase I Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study
- ClinicalTrials.gov ID
- NCT02392845
- Acronym / sponsor ID
- MODEL1 / 2004.356
- Conditions
- Metastatic Breast Cancer
- Keywords
- Drug combination, Accelerated chemotherapy, Mathematical model, Hematotoxicity, Individualized dosage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Mar 2015 (estimated)
- 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.
To determine the maximum tolerated dose of a densified regimen of the association of docetaxel (DTX) and epirubicin (EPI), supported by the concomitant administration of hematopoietic growth factors in patients with metastatic breast cancer in first-line, optimizing in each patient the administration schedule using a formal procedure based on mathematical models in order to manage the severity of induced neutropenia.
The models used in this project allow:
- an optimal administration schedule of the planned total dose per cycle (number of infusions and calculating their rates and durations)
- an individualization of the administration schedule from the second cycle (based on observations from the first cycle), and
- an assessment of the risk of a dose-limiting toxicity event combining several severe non-hematological toxicities (conditioning the decision for dose escalation).
Using formal mathematical models the investigators expect controlling the hematological and non-hematological toxicities in order to realize the full series of six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient. For each patient, chemotherapy is considered feasible if it is possible, in the absence of tumor progression, to consider 6 cycles of treatment without observing any serious adverse events and without:
- patient death that may be related to the treatments;
- decision of the patient to interrupt treatment for physical or psychological tolerance reasons;
- decision of the investigator to discontinue treatment, in the absence of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of Docetaxel (DTX) and Epirubicin (EPI) | Experimental | Drug: Combination of Docetaxel (DTX) and Epirubicin (EPI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years,
- ECOG performance status ≤ 2
- Diagnosed with metastatic HER2-negative hormone-resistant chemotherapy-naive breast cancers, previous adjuvant chemotherapy treatment are allowed.
- Histologically or cytologically proven breast cancer metastases or associated with CA 15-3 levels 50% above the normal value
- Hormone resistance defined by the presence of negative hormone receptors or disease progression within 6 months of the initiation of hormone therapy.
Key exclusion criteria (4 listed)
- Cerebral metastases and meningeal involvement,
- Other malignant diseases,
- Significant comorbidities,
- Previous chemotherapy for metastatic disease, or previous chemotherapy with a total cumulative dose greater than 600 mg/m² for EPI or greater than 450 mg/m² for DTX
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 |
|---|---|---|
| Combination of Docetaxel (DTX) and Epirubicin (EPI)Six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient | Drug | Combination of Docetaxel (DTX) and Epirubicin (EPI) |
Primary outcome
Assessment of the risk of Dose-limiting Toxicities
Time frame: 84 days (6 treatment cycles x 14 days)
DLTs were defined as ≥ grade 3 vomiting, ≥ grade 3 mucositis,≥ grade 3 hand-foot syndrome (HFS), grade 2 vomiting plus grade 2 mucositis, or grade 2 vomiting plus grade 2 HFS
4 secondary outcomes
Plasma concentration of Docetaxel and Epirubicin after administration
Time frame: 84 days (6 treatment cycles x 14 days)
Tumor response for each patient with one or more measurable lesions
Time frame: after 28 days (2 treatment cycles x 14 days) and 84 days (6 treatment cycles x 14 days)
Progression-free survival
Time frame: 115 days (study duration (6 treatment cycles x 14 days) + follow-up (31 days) when available)
Overall survival
Time frame: 115 days (study duration (6 treatment cycles x 14 days) + follow-up (31 days) when available)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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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.
Gilles FREYER, Professor principal investigator
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud - Service d'oncologie médicale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combination of Docetaxel (DTX) and Epirubicin (EPI) in people with Metastatic Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 10 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 1 site in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of the risk of Dose-limiting Toxicities (time frame: 84 days (6 treatment cycles x 14 days)). 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 10 Jun 2026.