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

Institut Curie

Status and phase: Unknown; Phase 3

Conditions: Ductal Infiltrating Metastatic Breast Cancer; Hormone-receptors Positive Breast Cancer

Treatments: Biological: Circulating tumor cells counting at baseline

Study type: Interventional

Funder types: Other

Identifiers

NCT01710605

IC 2011-09

Details and patient eligibility

About

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.

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

800 participants in 2 patient groups

Standard

Active Comparator group

Description:

Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information.

Treatment:

Biological: Circulating tumor cells counting at baseline

Circulating Tumor Cells

Experimental group

Description:

Treatment choices (hormonotherapy or chemotherapy) are done according to the number of CTC / 7.5 ml of blood at baseline : If \<5 CTC : Hormonotherapy If 5 or more CTC : chemotherapy

Treatment:

Biological: Circulating tumor cells counting at baseline