Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

Breast Cancer Clinical Trial

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 Details — Status: Suspended

Administrative data

• NCT number: NCT00738777
• Other study ID #: N08AFT
• Secondary ID: EudraCT; 2008-00
• Status: Suspended
• Phase: Phase 2
• Start date: July 2008
• Est. completion date: June 2024

Study information

• Verified date: January 2021
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 250
• Est. completion date: June 2024
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole
1 mg,QD,PO
• Anastrozole+Fulvestrant
Anastrozole; 1 mg, QD, PO Fulvestrant; 500 mg, IM, day 1, 15, 29 and monthly thereafter
• Tamoxifen
loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
• Tamoxifen
loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO

Locations

Country	Name	City	State
Netherlands	NKI-AVL	Amsterdam
Netherlands	Medisch Centrum Haaglanden	den Haag	ZH
Netherlands	St. Antonius ziekenhuis	Nieuwegein
Netherlands	UMC St. Radboud	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in tumor cell proliferation and induced apoptosis.		At baseline and after 2-6 weeks of endocrine treatment
Secondary	Comparison of changes in gene expression after different endocrine treatment exposures		At baseline and after endocrine treatment