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Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer

CompletedPhase 3

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Conditions: Breast Cancer

Interventions: Chemotherapy, Genomic driven chemotherapy

Countries: France

This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Invasive breast cancer not eligible for conservative surgery
* Her2 negative
* Amount of tumor cells \>30% on HES slides
* RIN\>6 and amount of RNA\>1 ug
* No metastases
* Subject, age \> 18 years and \<65 years old
* Signed written informed consent
* PS 0-1
* No previous treatment for breast cancer
* Adequate organ function
* FEVG \>50%

Exclusion Criteria:

* In situ carcinoma
* Multifocal cancers
* Her2+
* Presence of metastasis
* Genomic testing not feasible because of tumor cells \<30%, RIN\<6, insufficient amount of RNA
* Organ dysfunction that contraindicates chemotherapy

Locations (1)

Villejuif, France