Study of Exemestane After Anastrozole or Letrozole Treatment of Postmenopausal Women With Hormone Responsive Breast Cancer

NCT00902954 | Unknown Phase 3

• 1 other identifier: SHBCC0701
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the rate of disease free survival (DFS) and distant disease free survival (DDFS) at 5 years in postmenopausal women with hormone receptor and lymph node positive breast cancer randomized between anastrozole/letrozole 5 years and anastrozole/letrozole 2-3 years switching to exemestane 3-2 years.

Conditions

Breast Cancer

Keywords

Disease free survival; Distant disease free survival; Toxicity; Overall survival

Outcome Measures

Primary Outcomes (1)

• disease free survival

  at 6, 12, 24, 36 months, then once every year

Study Arms (2)

A

EXPERIMENTAL

anastrozole/letrozole 2-3 years switching to exemestane 3-2 years

Drug: anastrozole; Drug: letrozole; Drug: exemestane

B

ACTIVE COMPARATOR

anastrozole/letrozole 5 years

Drug: anastrozole; Drug: letrozole

Interventions

anastrozole DRUG

anastrozole 1 mg qd

A; B

letrozole DRUG

letrozole 2.5 mg qd

A; B

exemestane DRUG

exemestane 25 mg qd

A

Eligibility Criteria

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

You may qualify if:

• Provision of written informed consent.
• Patient muse be female.
• Patient must have undergone primary breast cancer surgery with institutional standard axillary dissection such as the following:
• A total mastectomy with institutional standard axillary nodal dissection.
• Lumpectomy or a quadrantectomy with institutional standard axillary dissection with breast radiotherapy (may be deferred until chemotherapy is completed) in accordance with breast preservation.
• Treatment of the breast cancer following diagnosis may have included any of the following; post-lumpectomy/quadrantectomy regional radiotherapy, post-mastectomy locoregional radiotherapy, postoperative chemotherapy, and trastuzumab.
• The tumor must have been pathologic primary invasive carcinoma by core needle or open biopsy.
• The beginning of endocrine therapy (letrozole or anastrozole) must be no more than 6 weeks from the end day of chemotherapy or radiotherapy.
• The date of randomization must be no less than 2 years of letrozole and no more than 3 years letrozole treatment.
• Positive node is defined as defined as the presence of at least micro metastasis greater than 0.2 mm according to the AJCC Breast Staging Criteria Edition 6.
• Patients who have had neoadjuvant chemotherapy are eligible. Positive lymph node involvement can be defined either prior of neoadjuvant chemotherapy or at the time of surgery following their neoadjuvant therapy. Lymph node positivity would be defined as the following:
• Pre-neoadjuvant chemotherapy lymph node assessment must include identification of a histological positive axillary, internal mammary or supraclavicular determined by one of the following: FNA of lymph node or sentinel lymph node evaluation, or complete or limited axillary dissection.
• For patients that have completed their neoadjuvant chemotherapy, without prior documentation of a positive lymph node, lymph node positivity must be demonstrated at the time of their primary surgery as defined by either:
• Either sentinel lymph node or primary axillary dissection identifying a positive lymph node is acceptable as per standard institutional practice guidelines.
• Histological evidence of a N1-N3c lymph node involvement identified at the time of primary breast surgery following neoadjuvant chemotherapy.

You may not qualify if:

• Presence of metastatic disease.
• Previous diagnosis of metachronous bilateral breast cancer.
• Previous or concomitant other (non-breast cancer) malignance within the previous 5 years except in situ carcinoma of the cervix or curatively treated basal and squamous cell.
• Presence of other non-malignant disease which may prevent prolonged follow-up.
• Received neoadjuvant endocrine therapy.
• Adjuvant SERMs therapy (Tamoxifen or Toremifene) for more than 6 months before randomization.
• Breast cancer chemoprevention with anti-estrogens if less than 18 months between stopping and diagnosis of breast cancer.
• Severe hepatic dysfunction defined as Child-Pugh grade C.
• Severe cardiac dysfunction defined above NYHA grade III.
• Presence of occult axillary lymph node with no evidence of primary breast tumor pathologically or DCIS with microinvasive. And the measurement of ER, PR and HER2 are not obtained.
• Uncontrolled psychological diseases.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Jinsong Lu

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Letrozole; exemestane

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

Study Officials

• Zhimin Shao, PhD, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JinSong Lu

CONTACT

86-13661671885; lussjj@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: March 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: May 15, 2009

Record last verified: 2009-05

Locations

CN (1)