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Breast CancerPhase 2HORGENNCT00871858

Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

A Phase 2 study testing anastrozole and fulvestrant in people with Breast Cancer, run by Institut Bergonié at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
anastrozole and fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteFrance
Study dates
18 Mar 2008to 2 Jul 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:
  • SBR grade I-II disease (patients < 65 years of age)
  • SBR grade I-III disease (patients > 65 years of age)
  • T2 (2-5 cm), T3, or T4B, and N0-1 disease
  • No metastatic disease
  • Breast lesion not amenable to breast-conserving resection
  • No inflammatory breast cancer
  • No prior breast cancer
  • Hormone receptor status:
  • Estrogen receptor- and/or progesterone receptor-positive

PATIENT CHARACTERISTICS:

  • Postmenopausal
  • No other cancer within the past 5 years except for adequately treated skin carcinoma or carcinoma in situ of the cervix
  • No contraindication to anti-hormonal treatment
  • No psychological, familial, social, or geographical reasons that would preclude follow up

PRIOR CONCURRENT THERAPY:

  • At least 8 days since prior hormone replacement therapy
  • No concurrent anti-vitamin K treatment

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Bergonie

    Bordeaux, 33076

Other trials in France

About this study

Official title: Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Non-metastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response.

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Given the lack of clinical data on fulvestrant in patients with large operable or locally advanced hormone-receptor-positive breast cancer, and the potential to identify differences in the mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre randomised phase II clinical trial of anastrozole and fulvestrant.

PURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate clinical tumor response at 6 months in patients with hormone-sensitive non-metastatic breast cancer treated with neoadjuvant anastrozole and fulvestrant.

Secondary

  • Evaluate tumor regression by mammography and ultrasound in these patients.
  • Evaluate the rate of breast conservation at 6 months of treatment in these patients.
  • Evaluate the tolerability of these regimens.
  • Estimate the relapse-free survival at 5 years.
  • Identify molecular signatures predictive of response in these patients.
  • Identify genes implicated in response in these patients.
  • Identify changes in mRNA splicing of genes involved in breast tumorigenesis.

OUTLINE: This is a non-comparative multicentre randomised phase II study in which patients from three French centres were randomly assigned in a 1 : 1 ratio to receive either anatrozole or fulvestrant.

All patients undergo biopsy at baseline. Patients are randomized between the two treatment arms.

  • Arm I: Patients receive oral anastrozole once daily for 6 months.
  • Arm II: Patients receive fulvestrant intramuscularly on days 1, 14, and 28 and then once a month at 2-6 months.

Within 8 days after completion of hormone therapy, all patients undergo surgical resection of the residual lesion followed by radiotherapy. Patients then receive oral anastrozole once daily for 5 years.

Tissue samples from biopsy and surgery are analyzed to assess molecular signatures and sensitivity to treatment, and to compare gene expression variation with response.

Conditions
Breast Cancer
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00871858
Study groupRoleWhat they receive
Arm A (ANA)Active comparatorPatients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.
Receives: Drug: anastrozole
Arm B (FULV)ExperimentalPatients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.
Receives: Drug: fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) Determined by Clinical Palpation

    Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.

    Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

    Measured: 6 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR) Determined by Ultrasound

    Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.

    Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

    Measured: 6 months

  2. Objective Response Rate (ORR) Determined by Mammography

    Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.

    Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

    Measured: 6 months

  3. Rate of Breast-conserving Surgery

    breast-conserving surgery concerns patients who did not undergo mastectomy.

    Measured: 6 months

  4. Percentage of Participants With 5-year Relapse-Free Survival

    Relapse-Free survival (RFS) is measured from the date of randomization to the date of the following events, whichever occurs first according to the DATECAN recommendations for breast cancer:

    • Invasive ipsilateral breast tumor recurrence/ progression ;
    • Local invasive recurrence/progression ;
    • Regional invasive recurrence/progression (N+: regional progression) ;
    • Appearance/Occurrence of Metastatic recurrence;
    • Death whatever the cause.

    Participants who did not experience events were censored at the date of last follow-up. RFS was estimated using the Kaplan-Meier method. No comparison test was performed between the two arms as this study is non-comparative.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2009 (estimated)
  2. Study start18 Mar 2008
  3. Primary completion30 Nov 2013
  4. Study completion2 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00871858
Sponsor's protocol ID
CDR0000633329
Other IDs
2007-004216-31
Acronym
HORGEN
Status last verified
Feb 2021
First submitted
27 Mar 2009
Last updated
24 Feb 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Quenel-Tueux N, Debled M, Rudewicz J, MacGrogan G, Pulido M, Mauriac L, Dalenc F, Bachelot T, Lortal B, Breton-Callu C, Madranges N, de Lara CT, Fournier M, Bonnefoi H, Soueidan H, Nikolski M, Gros A, Daly C, Wood H, Rabbitts P, Iggo R. Clinical and genomic analysis of a randomised phase II study evaluating anastrozole and fulvestrant in postmenopausal patients treated for large operable or locally advanced hormone-receptor-positive breast cancer. Br J Cancer. 2015 Aug 11;113(4):585-94. doi: 10.1038/bjc.2015.247. Epub 2015 Jul 14.

    PubMed 26171933

  • Lerebours F, Pulido M, Fourme E, Debled M, Becette V, Bonnefoi H, Rivera S, MacGrogan G, Mouret-Reynier MA, de Lara CT, Pierga JY, Breton-Callu C, Venat-Bouvet L, Mathoulin-Pelissier S, de la Motte Rouge T, Dalenc F, Sigal B, Bachelot T, Lemonnier J, Quenel-Tueux N. Predictive factors of 5-year relapse-free survival in HR+/HER2- breast cancer patients treated with neoadjuvant endocrine therapy: pooled analysis of two phase 2 trials. Br J Cancer. 2020 Mar;122(6):759-765. doi: 10.1038/s41416-020-0733-x. Epub 2020 Jan 31.

    PubMed 32001832

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anastrozole and fulvestrant in people with Breast Cancer, run by Institut Bergonié at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Determined by Clinical Palpation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00871858, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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