Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Immune System Diseases

Breast Neoplasms

Hypersensitivity

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Fulvestrant

Exemestane

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Aromatase Inhibitors

Enzyme Inhibitors

Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection

250 mg IM starting on Day 8 and then every 28 days.

Ewa Mrozek, MD

The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.

Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Response and progression was evaluated after every 2 cycles by physical examination and imaging studies using the international RECIST criteria.

Complete Response (CR), Partial Response (PR), Overall Response Rate (ORR), Stable Disease (SD), Progressive Disease (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions; Overall Response Rate (ORR), CR+PR

5 mL of venous whole blood was obtained before dosing and then at 1, 2, 4, 6, 8, and 24 hours after exemestane ingestion on each of the 2 time points.

Pfizer

Ohio State University Comprehensive Cancer Center

The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was used to assess adverse events for patients on this trial. The CTCAE using is a descriptive terminology that utilizes Adverse Event (AE) reporting.

Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection

Exemestane: 25 mg orally per day

Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days.

Single-arm Study

Exemestane and Fulvestrant

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Time From Primary Diagnosis to Metastatic Disease

During adjuvant endocrine therapy

>12 mo after completion adjuvant therapy

Presenting with de novo metastatic disease

Never on adjuvant hormonal therapy

Relapse and/or Progression

Ewa Mrozek

Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.

SD ≥ 6 Mo

Overall Clinical Benefit

SD< 6 Mo

Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)

Exemestane Alone (Day 7)

Exemestane + Fulvestrant (Day 120)

Only 9 patients had evaluable PK data collected and analyzed

Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant

Baseline

Day 7

Day 120

IGF-1

IGFBP-3-insulin-like growth factor-binding

IGFBP-3

Increase in mean levels from baseline to day 120. Not all patients had the IGF-1 and IGFBP-3 levels present.

Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels

Overall Study

Spots Global Cancer Trial Database for Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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