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

NCT00629616 | Completed Phase 2 DMC

• 4 other identifiers: CARMINA02CARMINA-02/06092006-006409-10NIMFEA
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Clinical tumor response as assessed by RECIST criteria

  6 months

Secondary Outcomes (8)

• Breast surgery conservation rate

  Post surgery

• Histological tumor response as assessed by the Sataloff scale

  Post surgery

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

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

• Biological prognosis and predictive response factors

  3 years

• Relapse-free survival rate

  3 years

Study Arms (2)

Arm A

EXPERIMENTAL

Anastrozole

Drug: anastrozole

Arm B

EXPERIMENTAL

Fulvestrant

Drug: fulvestrant

Interventions

anastrozole DRUG

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

Arm A

fulvestrant DRUG

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

Arm B

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (6)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Dupuytren

Limoges, 87042, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (3)

• 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.

  PMID: 27315583 RESULT

• 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.

  PMID: 32001832 DERIVED

• 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.

  PMID: 30305115 DERIVED

Related Links

• Cancer . 2016 Oct;122(19):3032-40. doi: 10.1002/cncr.30143. Epub 2016 Jun 17.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Florence Lerebours, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 6, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2015
• Study Completion: April 1, 2018
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

FR (6)