Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers

NCT00941330 | Completed Phase 2 Results

• 2 other identifiers: IRB00012969WCI1534-08
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.

Conditions

Breast Cancer

Keywords

Breast, Male; Breast, Female

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  Patients must have measurable disease by clinical examination. Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately. If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists.

  At time of definitive surgery

Secondary Outcomes (1)

• Response Rate by Imaging

  Every 2 months up to 3 years

Study Arms (2)

A: Exemestane

EXPERIMENTAL

ARM A: Patients will be treated with exemestane.

Drug: Exemestane

B: Docetaxel and Cytoxan

ACTIVE COMPARATOR

ARM B: Patients will be treated with docetaxel and cytoxan.

Drug: Docetaxel; Drug: Cytoxan

Interventions

Exemestane DRUG

25 mg daily by mouth for 6 to 12 months.

Also known as: Aromasin

A: Exemestane

Docetaxel DRUG

Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).

Also known as: Taxotere

B: Docetaxel and Cytoxan

Cytoxan DRUG

Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).

Also known as: Cyclophosphamide

B: Docetaxel and Cytoxan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Histologically or cytologically confirmed breast carcinoma.
• Early stage breast cancer (T1c-3, clinically node-negative-3 \[cN0-3\], CM0).
• Pre-treatment biopsy with the following characteristics:
• Hormone receptor-positive cancer as defined as ER and/or progesterone receptor (PR)-positive by standard immunohistochemistry (IHC)
• HER2-negative (HER2 ≤ 2 by IHC; if HER2 2+ by IHC must be fluorescent in situ hybridization \[FISH\] non-amplified)
• Recurrence score \< 25 using Oncotype DX 21-gene recurrence score assay
• Patients must have measurable disease as defined by palpable lesion with both diameters ≥ 1 cm measurable with caliper or a positive mammogram or ultrasound with at least one dimension ≥ 1 cm. Screening mammogram of the contralateral breast must be performed within past 12 months per standard practice guidelines. Clip placement is required for study entry.
• Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within 14 days of study enrollment if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a diagnostic mammogram of the affected breast or MRI must be done within 2 months prior to study enrollment, defined as date of signed, informed consent. If clinically indicated, staging xrays and scans must be done within 28 days of study entry.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
• Adequate organ function within 14 days of study entry:
• Bone marrow function: absolute neutrophil count (ANC) ≥ 1500/mm³, Hgb \> 8.0 g/dl and platelet count ≥ 100,000/mm³.
• Hepatic function: total bilirubin \< upper limit of normal (ULN). Serum glutamic oxaloacetic transaminase (SGOT) (AST) or serum glutamic pyruvic transaminase (SGPT) (ALT) and alkaline phosphatase ≤ 1.5 x ULN).
• Renal function: calculated creatinine clearance (CrCl) ≥ 30 mL/min using the Cockcroft Gault equation.
• Patients must be at least 18 years of age.

You may not qualify if:

• Evidence of disease outside the breast or chest wall, except ipsilateral axillary or internal mammary lymph nodes.
• Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
• Pregnant or lactating women are not eligible. Women of childbearing potential must have a negative serum pregnancy test completed within 7 days of study entry, and use an appropriate form of birth control throughout the trial period.
• Medical, psychological or surgical condition which the investigator feels might compromise study participation.
• Patients with history within the last 5 years of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.
• Evidence of peripheral or sensory neuropathy.
• Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 are excluded from participation.
• Serious, uncontrolled, concurrent infection(s).
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months prior to study entry.
• Major surgery within 28 days of study entry.
• Evidence of central nervous system (CNS) metastases.

Sponsors & Collaborators

• Emory University: lead
• Pfizer: collaborator

Study Sites (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Docetaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Jane Meisel, MD
• Organization: Emory University

jane.l.meisel@emory.edu

404-778-1900

Study Officials

• Elisavet Paplomata, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 17, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-02

Locations

US (3)