Ductal Infiltrating Metastatic Breast Cancer Clinical Trial
Official title:
Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.
| Verified date | April 2018 |
| Source | Institut Curie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.
| Status | Active, not recruiting |
| Enrollment | 800 |
| Est. completion date | September 2018 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Women with metastatic ductal adenocarcinoma breast cancer - 18 years old or more - Hormone receptors positive breast cancer (ER+ and/or PR+) on the last pathological analysis available. - Acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration - PS <4 - Life expectancy > 3 months - Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection - Information of the patient and signature of the informed consent form Exclusion Criteria: - Patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted) - Her2 positive breast cancer - History of other stage II or III cancer in the 5 years. History of other metastatic cancer (whatever the time between the two cancers). - Persons deprived of their freedom or under guardianship. - Women unable to comply with the medical follow-up of the study for geographical, social or mental reasons. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre François Baclesse | Caen | |
| France | Centre Georges Francois Leclerc | Dijon | |
| France | Clinique Victor Hugo | Le Mans | |
| France | Centre Leon Berard | Lyon | |
| France | Institut Paoli Calmettes | Marseille | |
| France | Chu Montpellier | Montpellier | |
| France | Institut régional du Cancer de Montpellier | Montpellier | |
| France | Centre Azureen de Cancerologie | Mougins | |
| France | Centre Antoine Lacassagne | Nice | |
| France | Hopital Europeen Georges Pompidou | Paris | |
| France | Hopital SAINT-LOUIS | Paris | |
| France | Hopital Tenon | Paris | |
| France | Institut Curie | Paris | |
| France | Institut Curie - Hopital Rene Huguenin | Saint-cloud | |
| France | Institut de Cancerologie de L'Ouest - Rene Gauducheau | Saint-herblain | |
| France | Institut Claudius Regaud | Toulouse | |
| France | Centre Alexis Vautrin | Vandoeuvre Les Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Curie |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression free survival evaluation | According to RECIST 1.1 criteria | 2 years | |
| Primary | Economic evaluation | Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice) | 2 years | |
| Secondary | Assessing patient quality of life | QLQC30 and BR23 individual questionaries | 2 years | |
| Secondary | Evaluation of treatment safety according to NCI-CTCAEv4.03 | Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization. | 2 years | |
| Secondary | Overall survival evaluation | 2 years |