Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer
This study is currently recruiting participants.
Verified May 2012 by The Netherlands Cancer Institute
Sponsor:
The Netherlands Cancer Institute
Collaborator:
AstraZeneca
Information provided by:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT00738777
First received: August 19, 2008
Last updated: May 10, 2012
Last verified: May 2012
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Purpose
To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Anastrozole Drug: Anastrozole+Fulvestrant Drug: Tamoxifen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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). |
Resource links provided by NLM:
Further study details as provided by The Netherlands Cancer Institute:
Primary Outcome Measures:
- Decrease in tumor cell proliferation and induced apoptosis. [ Time Frame: At baseline and after 2-6 weeks of endocrine treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Comparison of changes in gene expression after different endocrine treatment exposures [ Time Frame: At baseline and after endocrine treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Anastrozole
|
Drug: Anastrozole
1 mg,QD,PO
|
|
Experimental: 2
Anastrozole + Fulvestrant
|
Drug: Anastrozole+Fulvestrant
Anastrozole; 1 mg, QD, PO Fulvestrant; 500 mg, IM, day 1, 15, 29 and monthly thereafter
|
|
Active Comparator: 3
Tamoxifen
|
Drug: Tamoxifen
loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
|
|
4
Tamoxifen (pre-menopausal and male patients)
|
Drug: Tamoxifen
loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738777
Contacts
| Contact: Sabine C Linn, MD | +31-20-5129111 ext 2591 | s.linn@nki.nl |
| Contact: Rutger HT Koornstra, MD | +31-20-5129111 ext 6900 | r.koornstra@nki.nl |
Locations
| Netherlands | |
| NKI-AVL | Recruiting |
| Amsterdam, Netherlands, 1066 CX | |
| Contact: Sabine C Linn, MD +31-20-5129111 ext 2591 s.linn@nki.nl | |
| Contact: Rutger HT Koornstra, MD +31-20-5129111 ext 6900 r.koornstra@nki.nl | |
| Principal Investigator: Sabine C Linn, MD | |
| St. Antonius ziekenhuis | Not yet recruiting |
| Nieuwegein, Netherlands | |
| Contact: Paul C de Jong, MD | |
| Principal Investigator: Paul C de Jong, MD | |
| UMC St. Radboud | Recruiting |
| Nijmegen, Netherlands | |
| Contact: Hanneke W.M. Laarhoven, MD | |
| Principal Investigator: Hanneke W.M. Laarhoven, MD | |
Sponsors and Collaborators
The Netherlands Cancer Institute
AstraZeneca
Investigators
| Principal Investigator: | Sabine C Linn, MD | NKI-AvL |
More Information
No publications provided
| Responsible Party: | S.C. Linn, MD, NKI-AVL |
| ClinicalTrials.gov Identifier: | NCT00738777 History of Changes |
| Other Study ID Numbers: | N08AFT, EudraCT; 2008-000644-13 |
| Study First Received: | August 19, 2008 |
| Last Updated: | May 10, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by The Netherlands Cancer Institute:
|
pre-operative endocrine treatment drug resistance |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Fulvestrant Anastrozole Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013