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Breast CancerPhase 2NCT00128843

Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients

A Phase 2 study testing Exemestane and Anastrozole in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 13 sites in Spain.

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

This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One hundred postmenopausal patients, with metastatic, positive hormone receptor breast cancer will be enrolled in this trial. Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Exemestane and Anastrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
13 sitesSpain
Study dates
Aug 2001to Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

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 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathological diagnoses of breast cancer.
  • Postmenopausal women, defined as:
  • Bilateral surgical oophorectomy or amenorrhoea >= 5 years;
  • Age >= 56 years old and amenorrhoea >= 1 year;
  • Chemotherapy induced amenorrhoea >= 2 years;
  • Radiotherapy induced amenorrhoea at least 3 months before:
Show all 17Show fewer
  • Age < 56 and < 5 years of amenorrhoea: follicle-stimulating hormone (FSH) levels to confirm postmenopausal status.
  • Metastatic breast cancer (stage IV) or non-operable locally advanced breast cancer (stage IIIB).
  • Positive estrogen and/or progesterone receptors as >10% cells or >10fmol/mg.
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Patients who have received adjuvant tamoxifen are eligible, if progression has been established at least 24 months since treatment start.
  • Neoadjuvant chemotherapy is allowed if progression has been established at least 12 months after end of treatment.
  • Patients may have received a first line of chemotherapy for advanced disease, but treatment must have ended at least 4 weeks before enrolment, and all acute toxicities must be resolved. Previous treatment with Herceptin is allowed.
  • Normal haematological, hepatic and renal functions.
  • Performance status ECOG of 0, 1, 2.
  • Life expectancy superior to 3 months.
  • Written informed consent.

Who cannot join

  • Previous hormone treatment for metastatic disease.
  • Previous treatment with aromatase inhibitors.
  • Inflammatory breast cancer, or aggressive metastatic disease, or visceral lesions, or metastasis in the central nervous system (CNS).
  • Non-measurable disease.
  • Second malignancy except for basal skin carcinoma or cervical in situ carcinoma adequately treated. If other malignancies, patient must have a disease-free period superior to 5 years.
  • Treatment with any investigational product in the 4 previous weeks.
  • Patients with negative estrogen and progesterone receptor tumours.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Spain13 sites

  • Clínico Universitario A Coruña (CHUAC)

    A Coruña, Galicia

  • Germans Trias i Pujol

    Badalona, Barcelona

  • H Comarcal de Barbastro

    Barbastro, Huesca

  • Onkologikoa

    Donostia / San Sebastian, Guipúzcoa, 20012

  • Hospital Donostia

    Donostia / San Sebastian, Guipúzcoa, 20014

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Puerta de Hierro

    Madrid

  • Ruber Internacional

    Madrid

  • H Puerto de Sagunto

    Sagunto, Valencia

  • H Sant Camil

    Tarragona

  • Instituto Valenciano de Oncología (IVO)

    Valencia, 46009

  • Clínico Lozano Blesa

    Zaragoza

  • H Universitario Miguel Servet

    Zaragoza

Other trials in Spain

About this study

Official title: Phase II Randomized, Multicenter, Crossover Clinical Trial for Administration of Exemestane vs. Anastrozole as First Line Treatment for Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer

This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One hundred postmenopausal patients, with metastatic, positive hormone receptor breast cancer will be enrolled in this trial.

Read the detailed description

The primary study endpoint is objective response rate. The study has been designed following Simon's test, with a p1-p0=0.15. p1 is the optimum level of activity of the experimental treatment (exemestane), and p0 is the minimum expected activity. In this study, p1 is 25% (25% of RR) and p0 is 10% (10% of RR). With an alpha error of 0.05 and a beta error of 0.1, Simon test establishes a first step of 21 patients per treatment arm. If at least 2 objective responses are observed in exemestane arm, recruitment will continue until 100 patients have been recruited. After this second recruitment phase, at least 7 objective responses must be observed to confirm the expected exemestane level of activity.

Conditions
Breast Cancer
Being tested
Exemestane, Anastrozole
Keywords
Metastatic breast cancer, First line of hormone treatment, Postmenopausal women, Positive hormone receptor tumours
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ExemestaneDrug

    Also called Aromasil

    25mg/day until progression disease

  • AnastrozoleDrug

    Also called Arimidex

    1mg/day until progression disease

Study groups in NCT00128843
Study groupRoleWhat they receive
ExemestaneExperimental25mg/day per VO until progression disease, after this progression the patient could receive the another drug (comparator arm) ie Anastrozole by investigator decision
Receives: Drug: Anastrozole
AnastrozoleActive comparator1mg/day per VO until progression disease, after this progression the patient could receive the another drug (experimental arm) ie Exemestane by investigator decision
Receives: Drug: Exemestane

What is being measured

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

  1. Overall Response Rate (ORR) in both arms

    Complete response plus partial response

    Measured: up to 12 months

Secondary outcomes (8)

  1. Time to progression

    Time from last patient included to progression disease

    Measured: From date of randomization until the date of new documented progression, assessed up to 24 months

  2. Time to progression after crossover

    Time from crossover (2nd line) to progression disease

    Measured: From date of crossover until the date of new documented progression, assessed up to 5 months

  3. Clinical benefit (1st line)

    Completed response (CR) plus Partial Response (PR) plus Stable Diasease (SD) lasting ≥6 months

    Measured: up to 6 months

  4. Clinical benefit after crossover (2nd line)

    Completed response (CR) plus Partial Response (PR) plus Stable Diasease

    Measured: up to 6 months

  5. Survival

    Time from randomization of last patient included until death whatever cause.

    Measured: up to 36 months

  6. Survival after crossover

    Time from crossover until death whatever cause.

    Measured: up to 24 months

  7. The Number of Participants Who Experienced Adverse Events (AE)

    Patients who will receive at least one dose of Exemestane or Anastrozole will be evaluated for safety and toxicity. Safety will be assess by recording all clinical adverse events at each patient.

    Measured: Until 30 days after the end of last patient study treatment (1st line)

  8. Toxicity after crossover

    Patients who will receive at least one dose of Exemestane or Anastrozole will be evaluated for safety and toxicity. Safety will be assess by recording all clinical adverse events at each patient.

    Measured: Until 30 days after the end of last patient study treatment (crossover: 2nd line)

Timeline

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

  1. First posted10 Aug 2005 (estimated)
  2. Study startAug 2001
  3. Primary completionJul 2005
  4. Study completionOct 2014

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
Crossover
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00128843
Sponsor's protocol ID
GEICAM 2001-03
Status last verified
Mar 2023
First submitted
9 Aug 2005
Last updated
6 Mar 2023
Results posted
No
Data monitoring committee
No

Publications

  • Llombart-Cussac A, Ruiz A, Anton A, Barnadas A, Antolin S, Ales-Martinez JE, Alvarez I, Andres R, Garcia Saenz JA, Lao J, Carrasco E, Camara C, Casas I, Martin M. Exemestane versus anastrozole as front-line endocrine therapy in postmenopausal patients with hormone receptor-positive, advanced breast cancer: final results from the Spanish Breast Cancer Group 2001-03 phase 2 randomized trial. Cancer. 2012 Jan 1;118(1):241-7. doi: 10.1002/cncr.26299. Epub 2011 Jun 29.

    PubMed 21717449

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exemestane and Anastrozole in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 13 sites in Spain.

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

Who may be eligible to take part?

The sponsor lists 17 inclusion and 7 exclusion criteria. 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 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Response Rate (ORR) in both arms (time frame: up to 12 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 NCT00128843, which also lists 1 linked publication.

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 6 Mar 2023.

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