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Completed

NCT Number: NCT01127295

Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

This is a biomedical study of interventional type, multicenter, inter-regional.

Patients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. The main objective is to estimate the correlations between pharmacokinetic and pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3 years.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Clinique Calabet, Agen, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient of more than 18 years old (menopaused or not)
  • Invasive breast cancer non-metastatic locally controlled by surgery with or without radiotherapy. Previous treatment with chemotherapy is allowed including trastuzumab
  • Cancer hormone-expressing ER and / or PR (> 10% tumor cells in Technical HIC)
  • Having a staging exploring bone, liver, lung and showing no abnormality secondary (for sub-centimeter tumors, the staging is not necessary)
  • WHO <2
  • Before the initiation of adjuvant hormonal therapy (tamoxifen, anastrozole, letrozole or exemestane) and whatever the approach chosen by the investigator (5 years of tamoxifen, 5 years of anti-aromatase or sequential patterns)
  • signed Consent collected before any specific procedure in the study
  • Patient member in a national insurance scheme.

Exclusion criteria

  • Patient previously treated for breast cancer receiving hormonal therapy with tamoxifen, anastrozole, letrozole or exemestane regardless of the scheme
  • Metastatic Breast cancer
  • History of another cancer diagnosed within 5 years before or uncontrolled except carcinoma in situ of cervix carcinoma, nonmelanoma skin, breast cancer (in this case, treatment with hormone therapy should be stopped for at least 6 months)
  • Any other medical or psychiatric condition or laboratory abnormality severe acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator
  • Patient unable to follow procedures, visits, examinations described in the study
  • Pregnant women or nursing mothers can not participate in the study
  • Women of childbearing age must use effective contraception at study entry and up to at least three months after the end of treatment
  • Patient under legal guardianship

Treatment and study plan

Tamoxifen, Letrozole, Anastrozole or Exemestane

Drug

Tamoxifen 20 mg/day during 5 years Létrozole 2.5 mg/day during 5 years Anastrozole 1 mg/day during 5 years Exémestane 25 mg/day during 5 years

Primary outcomes

  1. Correlation between pharmacokinetic and pharmacogenetic parameters

    Time frame: 9 years

    To estimate the correlations between pharmacokinetic and pharmacogenetic parameters of hormonal adjuvant breast cancer treatment during the first 3 years.

Secondary outcomes

  1. To estimate the relation between plasmatic concentrations, pharmacogenetic characteristic and adverse effects.

    Time frame: 9 years

  2. To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment

    Time frame: 9 years

  3. To estimate the link between plasmatic concentrations and the premature relapse (in the first 3 years)

    Time frame: 9 years

  4. To estimate the declared therapeutic observance to the real exposure at the treatment measured by plasmatic concentrations.

    Time frame: 9 years

  5. appearance auto-antibody and correlate to the clinical data

    Time frame: 9 years

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Official study title

Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

Acronym: PHACS

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
May 20, 2010
Registry last updated
Apr 14, 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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