Anastrozole or Fulvestrant in Treating Postmenopausal Women With Stage II or Stage III Breast Cancer That Can Be Removed By Surgery - Full Text View

Sponsored by:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00629616

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: anastrozole Drug: fulvestrant Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: radiation therapy Procedure: therapeutic conventional surgery	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Ici 182780 Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
Official Title:	A Randomized Multicenter Phase II Study Identifying Hormonosensivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-Adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Clinical tumor response at 6 months as assessed by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:

Breast surgery conservation rate [ Designated as safety issue: No ]
Histological tumor response as assessed by the Sataloff scale [ Designated as safety issue: No ]
Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI at baseline, after the first month of treatment, and then before surgery [ Designated as safety issue: No ]
Biological prognosis and predictive response factors [ Designated as safety issue: No ]
Relapse-free survival rate at 3 years [ Designated as safety issue: No ]
Event-free survival rate at 3 years [ Designated as safety issue: No ]
Overall survival rate at 3 years [ Designated as safety issue: No ]
Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment:	116
Study Start Date:	August 2007
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629616

Locations

France
Centre Eugene Marquis	Recruiting
Rennes, France, 35042
Contact: Contact Person 33-2-9925-3000
Centre Jean Perrin	Recruiting
Clermont-Ferrand, France, 63011
Contact: Contact Person 33-73-278-080
Centre Paul Strauss	Recruiting
Strasbourg, France, 67065
Contact: Contact Person 33-3-8825-2424
Institut Gustave Roussy	Recruiting
Villejuif, France, F-94805
Contact: Contact Person 33-1-4211-4339
Institut Curie Hopital	Recruiting
Paris, France, 75248
Contact: Contact Person 33-44-32-4000
Centre Rene Huguenin	Recruiting
Saint Cloud, France, 92211
Contact: Contact Person 33-147-111-529 m.tubiana@stcloud-huguenin.org

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Investigator:

Michelle Tubiana-Hulin, MD

Centre Rene Huguenin

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000585501, FNCLCC-CARMINA-02/0609, EU-20805, FNCLCC-NIMFEA, ZENECA-FNCLCC-CARMINA-02-0609
Study First Received:	March 5, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00629616
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Anastrozole
Skin Diseases
Guaifenesin

Phenylephrine
Fulvestrant
Breast Neoplasms
Phenylpropanolamine
Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009