Clinical Trials /

Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

NCT00738777

Description:

To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer
  • Official Title: A Randomized, Prospective Trial of 2-6 Weeks Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - Response in Molecular Profile (AFTER-study).

Clinical Trial IDs

  • ORG STUDY ID: N08AFT
  • SECONDARY ID: EudraCT; 2008-000644-13
  • NCT ID: NCT00738777

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Anastrozole1
Anastrozole+Fulvestrant2
Tamoxifen3
Tamoxifen4

Purpose

To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.

Detailed Description

      We will perform a randomized, open-label, single-institution study. It will compare the
      efficacy of three different endocrine treatment regimens (Anastrozole +/- Fulvestrant or
      Tamoxifen) in changing proliferation-index and inducing apoptosis during a 2-6 week
      pre-operative treatment period in breast cancer patients. These results will be correlated to
      gene expression profiles, phosphorylation status of the ER, SNPs in CYP450 sequences,
      tamoxifen metabolite concentrations, changes in estrogen serum levels and protein expression
      patterns.
    

Trial Arms

NameTypeDescriptionInterventions
1Active ComparatorAnastrozole
  • Anastrozole
2ExperimentalAnastrozole + Fulvestrant
  • Anastrozole+Fulvestrant
3Active ComparatorTamoxifen
  • Tamoxifen
4OtherTamoxifen (pre-menopausal and male patients)
  • Tamoxifen

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with proven invasive adenocarcinoma of the breast

          -  Any tumor with a size ≥ 1cm (NOT inflammatory breast cancer)

          -  WHO-performance score 0 or 1

          -  Written informed consent

        Exclusion Criteria:

          -  Clues of metastatic disease by clinical examination according to most recent NABON
             guidelines

          -  Multicentric breast cancer

          -  Inflammatory breast cancer

          -  Hormone replacement during the last 12 months

          -  Other systemic treatment during the waiting time till surgery

          -  Already planned date for surgery within the next 2 weeks

          -  Any psychological, familial, sociological or geographical condition potentially
             hampering adequate informed consent or compliance with the study protocol

          -  Patient's refusal to undergo a core biopsy procedure of the primary tumor before the
             start of treatment

        NB: a concomitant malignancy within the last five years is not an exclusion criterium,
        because survival is not the primary endpoint. Just as prior invasive breast cancer or DCIS
        within the last 15 years is not an exclusion criterium.

        NB: Patients of childbearing potential must implement adequate non-hormonal contraceptive
        measures during the study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Decrease in tumor cell proliferation and induced apoptosis.
Time Frame:At baseline and after 2-6 weeks of endocrine treatment
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Comparison of changes in gene expression after different endocrine treatment exposures
Time Frame:At baseline and after endocrine treatment
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The Netherlands Cancer Institute

Trial Keywords

  • pre-operative
  • endocrine treatment
  • drug resistance

Last Updated

September 13, 2017