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Adherence to Oral Therapies in Advanced Breast and Prostate Cancers (AdOTAC)

I

Institut de Cancérologie de Lorraine

Status

Enrolling

Conditions

Breast Cancer
Prostate Cancer

Treatments

Other: Adherence to anti-cancer therapies questionnaires
Diagnostic Test: Blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT06435546
2024-A00396-41

Details and patient eligibility

About

AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Blood samples are collected the day of enrolment (Day 0) in order to measure the following biological markers: ferritin, serum iron, TSAT, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult over 18 years old.
  • Patient with inoperable advanced breast cancer treated with oral endocrine therapy and/or targeted therapy and patient with inoperable advanced prostate cancer treated with oral hormonal therapy and/or targeted therapy.
  • Oral anticancer medications started for at least 3 months.
  • With a performance status ≤ 3.
  • Patient has understood, signed and dated the consent form.
  • Patient covered by the social security system.

Exclusion criteria

  • Patient with early breast cancer or localized prostate cancer.
  • Patient with life expectancy < 3 months.
  • Patient in progression
  • Undergoing intravenous or oral cytotoxic chemotherapy (capecitabine, cyclophosphamide, vinorelbine).
  • Patient who has not yet started oral anticancer therapies or who has started for less than 3 months.
  • Patient unable to read or speak French.
  • Patient already included in another therapeutic trial with an experimental molecule.
  • Persons deprived of their liberty or under guardianship (including curatorship).

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

Adherence oral anticancer therapies questionnaire
Experimental group
Description:
Blood samples
Treatment:
Diagnostic Test: Blood samples
Other: Adherence to anti-cancer therapies questionnaires

Trial contacts and locations

1

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Central trial contact

Jean-Louis Merlin, Pr; Vincent Massard, MD

Data sourced from clinicaltrials.gov

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