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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03154 | Registry Identifier | Clinical Trial Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm study | Experimental | Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exemestane | Drug | 25 mg orally per day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant. | 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 | Every 2 cycles up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease) | 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 |
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Inclusion Criteria:
Proven breast cancer
Metastatic or locally advanced breast cancer
Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)
Postmenopausal status
No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Adequate organ function
Exclusion Criteria:
No prior Exemestane or Fulvestrant
Uncontrolled intercurrent illness including but not limited to:
Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.
Presence of bleeding diathesis or coagulopathy, patients requiring coumadin
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| Name | Affiliation | Role |
|---|---|---|
| Ewa Mrozek, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22444722 | Result | Mrozek E, Layman R, Ramaswamy B, Schaaf L, Li X, Ottman S, Shapiro CL. Phase II trial of exemestane in combination with fulvestrant in postmenopausal women with advanced, hormone-responsive breast cancer. Clin Breast Cancer. 2012 Apr;12(2):151-6. doi: 10.1016/j.clbc.2012.01.003. |
| Label | URL |
|---|---|
| Jamesline | View source |
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Patients were enrolled between November 2005 and December 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Exemestane and Fulvestrant | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exemestane and Fulvestrant | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant. | 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 | Posted | Median | 95% Confidence Interval | months | Every 2 cycles up to 2 years |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-arm Study | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 2 according to NCI Common Terminology Criteria for Adverse Events (CTCAE v.3.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ewa Mrozek | The Ohio State University | 614-293-7956 | Ewa.Mrozek@osumc.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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| Fulvestrant | Drug | 250 mg IM starting on Day 8 and then every 28 days. |
|
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| Every 2 cycles, up to 1 year |
| Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant | 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. | Day 7 and Day 120 |
| Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels | Prestudy, Day 7 and Day 120 |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time From Primary Diagnosis to Metastatic Disease | Median | Full Range | years |
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| Relapse and/or Progression | Number | participants |
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|
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| Secondary | Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease) | 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 | Posted | Number | patients | Every 2 cycles, up to 1 year |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant | 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. | Only 9 patients had evaluable PK data collected and analyzed | Posted | Mean | Standard Deviation | ng/ml | Day 7 and Day 120 |
|
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|
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| Secondary | Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels | Increase in mean levels from baseline to day 120. Not all patients had the IGF-1 and IGFBP-3 levels present. | Posted | Mean | Standard Deviation | ng/mL | Prestudy, Day 7 and Day 120 |
|
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|
| 6 |
| 40 |
| 24 |
| 40 |
| Thromboembolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 2 and Grade 3 according to NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0) |
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| Thrombocytopenia | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment | Grade 2 according to NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0) |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Grade 2 and Grade 3 according to NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0) |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Title | Measurements |
|---|
|
| SD ≥ 6 Mo |
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| Overall Clinical Benefit |
|
| SD< 6 Mo |
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| PD |
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| Day 120 |
|