CompletedPhase 2

Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+

France140 participantsStarted 2009-09

Plain-language summary

The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +. The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Pregnant or Breastfeeding women
✓. Use of St. John's Wort (herbal tea ...) within 5 days before starting treatment
✓. Consumption of grapefruit juice in the last 5 days of starting treatment
✓. Congenital galactosemia
✓. Glucose and galactose malabsorption
✓. Lactase deficiency
✓. Co-medications that may interfere with cytochrome P450:
✓. Ongoing Enzyme inducers:

What they're measuring

Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer

Timeframe: 5 weeks

Trial details

NCT IDNCT01220076

SponsorInstitut Cancerologie de l'Ouest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

View on ClinicalTrials.gov More Non Metastatic Breast Cancer trials