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Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

Primary Purpose

Breast Cancer

Status
Suspended
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Anastrozole
Anastrozole+Fulvestrant
Tamoxifen
Tamoxifen
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring pre-operative, endocrine treatment, drug resistance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medisch Centrum Haaglanden
  • NKI-AVL
  • St. Antonius ziekenhuis
  • UMC St. Radboud

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Other

Arm Label

1

2

3

4

Arm Description

Anastrozole

Anastrozole + Fulvestrant

Tamoxifen

Tamoxifen (pre-menopausal and male patients)

Outcomes

Primary Outcome Measures

Decrease in tumor cell proliferation and induced apoptosis.

Secondary Outcome Measures

Comparison of changes in gene expression after different endocrine treatment exposures

Full Information

First Posted
August 19, 2008
Last Updated
January 20, 2021
Sponsor
The Netherlands Cancer Institute
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00738777
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).
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Suspended
Why Stopped
in preparation for an amendment
Study Start Date
July 2008 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
pre-operative, endocrine treatment, drug resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Anastrozole
Arm Title
2
Arm Type
Experimental
Arm Description
Anastrozole + Fulvestrant
Arm Title
3
Arm Type
Active Comparator
Arm Description
Tamoxifen
Arm Title
4
Arm Type
Other
Arm Description
Tamoxifen (pre-menopausal and male patients)
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Intervention Description
1 mg,QD,PO
Intervention Type
Drug
Intervention Name(s)
Anastrozole+Fulvestrant
Intervention Description
Anastrozole; 1 mg, QD, PO Fulvestrant; 500 mg, IM, day 1, 15, 29 and monthly thereafter
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
Primary Outcome Measure Information:
Title
Decrease in tumor cell proliferation and induced apoptosis.
Time Frame
At baseline and after 2-6 weeks of endocrine treatment
Secondary Outcome Measure Information:
Title
Comparison of changes in gene expression after different endocrine treatment exposures
Time Frame
At baseline and after endocrine treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine C Linn, MD
Organizational Affiliation
NKI-AvL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Centrum Haaglanden
City
den Haag
State/Province
ZH
Country
Netherlands
Facility Name
NKI-AVL
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
St. Antonius ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

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