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Breast CancerPhase 2NIMFEANCT00629616

Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer

A Phase 2 study testing anastrozole and fulvestrant in people with Breast Cancer, run by UNICANCER at 6 sites 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 or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Read more about this study

Who is it for?
Any age, 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
116 participants
Where
6 sitesFrance
Study dates
Oct 2007to Apr 2018
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed infiltrating breast adenocarcinoma
  • Large, operable tumor
  • Stage T2 (≥ 3 cm) or T3-T4 (excluding inflammatory disease), N0-N3, M0 disease
  • No bilateral inflammatory breast tumors (T4d [PEV-2 or PEV-3])
  • Elston-Ellis grade I or II and mitotic index 1 or 2 (if < 65 years of age)
  • At least 1 embedded and 1 frozen biopsy sample available
  • No multifocal or multicentric tumors for which breast conservation cannot be envisaged
  • No ErbB2-overexpressing tumors (HER2 3+ by IHC OR HER2 2+ by IHC and FISH positive)
  • Hormone receptor status:
  • Estrogen receptor and/or progesterone receptor positive tumor (> 10%) as assessed by IHC

PATIENT CHARACTERISTICS:

  • Female
  • Postmenopausal
  • ECOG performance status 0-2
  • ANC ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.25 times ULN
  • AST and ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No other cancer within the past 10 years, except basal cell skin cancer or previously treated carcinoma in situ of the cervix
  • No uncontrolled cardiac pathology, including any of the following:
  • Angina pectoris
  • Congestive cardiac insufficiency
  • Myocardial infarction within the past 3 months
  • No known history of hemorrhagic diathesis
  • No known allergy to the study drugs or their excipients
  • No congenital galactosemia, glucose malabsorption syndrome, or lactase deficiency
  • No chronic somatic or psychiatric illness with pejorative prognosis
  • No geographical, social, or psychiatric condition that would preclude study compliance and follow-up schedule
  • No individual deprived of liberty or placed under the authority of a tutor

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy, hormonal therapy, or any targeted treatment for the breast tumor
  • At least 2 weeks since prior hormone replacement therapy for menopause
  • No concurrent long-term anticoagulation treatment
  • No concurrent participation on another therapeutic trial involving an experimental molecule

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Dupuytren

    Limoges, 87042

  • Institut Curie Hopital

    Paris, 75248

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: A Randomized Multicenter Phase II Study Identifying Hormone Sensitivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To compare the clinical response rates (complete and partial responses) at 6 months in postmenopausal women with operable stage II or III breast cancer treated with neoadjuvant anastrozole vs fulvestrant.

Secondary

  • To compare the breast surgery conservation rate in patients treated with these drugs.
  • To correlate imaging findings by mammography, ultrasonography, and MRI with histological and clinical response in these patients and with sensitivity profile to these drugs.
  • To compare histological response in patients treated with these drugs.
  • To define criteria appropriate for neoadjuvant hormonal therapy.
  • To correlate baseline molecular characteristics and modifications during treatment with response in these patients.
  • To compare the tolerability of these drugs in these patients.
  • To compare the serum proteomic profile of patients treated with these drugs.
  • To correlate 3-year event-free and overall survival rates with clinical and histological response in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral anastrozole once daily for 4-6 months in the absence of clinical progression.
  • Arm II: Patients receive fulvestrant intramuscularly on days 1, 15, and 29 in the first month and then every 28 days in each subsequent month. Treatment continues for 4-6 months in the absence of clinical progression.

Patients in both arms then undergo surgery and radiotherapy according to institutional guidelines. Patients then receive adjuvant hormonal therapy for at least 5 years.

After completion of study therapy, patients are followed periodically for up to 3 years.

Conditions
Breast Cancer
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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.

  • anastrozoleDrug

    1 mg/day for either 4 months or 6 months depending on the clinical evaluation

  • fulvestrantDrug

    500mg at day 1, day 15 and day 29 500mg every 28 days for either 4 months or 6 months depending on the clinical evaluation

Study groups in NCT00629616
Study groupRoleWhat they receive
Arm AExperimentalAnastrozole
Receives: Drug: anastrozole
Arm BExperimentalFulvestrant
Receives: Drug: fulvestrant

What is being measured

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

  1. Clinical tumor response as assessed by RECIST criteria

    Measured: 6 months

Secondary outcomes (8)

  1. Breast surgery conservation rate

    Measured: Post surgery

  2. Histological tumor response as assessed by the Sataloff scale

    Measured: Post surgery

  3. Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI

    Measured: at baseline, after the first month of treatment, and then before surgery

  4. Biological prognosis and predictive response factors

    Measured: 3 years

  5. Relapse-free survival rate

    Measured: 3 years

  6. Event-free survival rate

    Measured: 3 years

  7. Overall survival rate

    Measured: 3 years

  8. Toxicity as assessed by NCI CTCAE v3.0

    Measured: During neoadjuvant treatment

Timeline

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

  1. First posted6 Mar 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionJun 2015
  4. Study completionApr 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
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00629616
Sponsor's protocol ID
CARMINA02
Other IDs
CARMINA-02/0609, 2006-006409-10, NIMFEA
Acronym
NIMFEA
Status last verified
Jun 2021
First submitted
5 Mar 2008
Last updated
9 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lerebours F, Rivera S, Mouret-Reynier MA, Alran S, Venat-Bouvet L, Kerbrat P, Salmon R, Becette V, Bourgier C, Cherel P, Boussion V, Balleyguier C, Thibault F, Lavau-Denes S, Nabholz JM, Sigal B, Trassard M, Mathieu MC, Martin AL, Lemonnier J, Mouret-Fourme E. Randomized phase 2 neoadjuvant trial evaluating anastrozole and fulvestrant efficacy for postmenopausal, estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients: Results of the UNICANCER CARMINA 02 French trial (UCBG 0609). Cancer. 2016 Oct;122(19):3032-40. doi: 10.1002/cncr.30143. Epub 2016 Jun 17.

    PubMed 27315583

  • 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

  • Liang X, Briaux A, Becette V, Benoist C, Boulai A, Chemlali W, Schnitzler A, Baulande S, Rivera S, Mouret-Reynier MA, Bouvet LV, De La Motte Rouge T, Lemonnier J, Lerebours F, Callens C. Molecular profiling of hormone receptor-positive, HER2-negative breast cancers from patients treated with neoadjuvant endocrine therapy in the CARMINA 02 trial (UCBG-0609). J Hematol Oncol. 2018 Oct 11;11(1):124. doi: 10.1186/s13045-018-0670-9.

    PubMed 30305115

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 UNICANCER at 6 sites in France.

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

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?

Clinical tumor response as assessed by RECIST criteria (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 NCT00629616, which also lists 3 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 9 Jun 2021.

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