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NCT Number: NCT02392845

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

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Gilles FREYER , Professor 04 78 86 43 18 Ext. +33 [email protected]

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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),
  • Adequate cardiac function (left ventricular ejection fraction (LVEF) > 50%),
  • Neutrophils ≥ 1200/mm3
  • Platelets ≥ 105/mm3

Exclusion criteria

  • 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

Treatment and study plan

Combination of Docetaxel (DTX) and Epirubicin (EPI)

Drug

Six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient

Primary outcomes

  1. 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

Secondary outcomes

  1. Plasma concentration of Docetaxel and Epirubicin after administration

    Time frame: 84 days (6 treatment cycles x 14 days)

    Assessment of the pharmacokinetics of Docetaxel and Epirubicin

  2. 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)

    Measurement of tumor response by MRI for each patient with one or more measurable lesions, classified according to RECIST criteria

  3. Progression-free survival

    Time frame: 115 days (study duration (6 treatment cycles x 14 days) + follow-up (31 days) when available)

  4. Overall survival

    Time frame: 115 days (study duration (6 treatment cycles x 14 days) + follow-up (31 days) when available)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: MODEL1

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Mar 19, 2015
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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