Trial Outcomes & Findings for Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers (NCT NCT00941330)
NCT ID: NCT00941330
Last Updated: 2017-04-10
Results Overview
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.
COMPLETED
PHASE2
31 participants
At time of definitive surgery
2017-04-10
Participant Flow
From June 2009 to December 2014, patients were recruited at Winship Cancer Institute of Emory University, Emory University Hospital Midtown, and Grady Health System, all in Atlanta, Georgia.
Five patients were not assigned to a treatment arm. One patient was ineligible for the study due to a low Oncotype score. Three patients did not like randomized treatment. One patient had disease progression.
Participant milestones
| Measure |
A: Exemestane
ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months.
|
B: Docetaxel and Cytoxan
ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
|
Overall Study
COMPLETED
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
A: Exemestane
ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months.
|
B: Docetaxel and Cytoxan
ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
|
|---|---|---|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
Baseline characteristics by cohort
| Measure |
A: Exemestane
n=15 Participants
ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months.
|
B: Docetaxel and Cytoxan
n=11 Participants
ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of definitive surgeryPopulation: One patient in Arm B did not have surgery.
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.
Outcome measures
| Measure |
A: Exemestane
n=14 Participants
ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months.
|
B: Docetaxel and Cytoxan
n=8 Participants
ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
|
|---|---|---|
|
Pathologic Complete Response
Downstaged
|
5 Participants
|
1 Participants
|
|
Pathologic Complete Response
Stable
|
4 Participants
|
2 Participants
|
|
Pathologic Complete Response
Upstaged
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Every 2 months up to 3 yearsPopulation: Data were not available for 5 patients (4 withdrew and 1 did not have surgery).
Arm A and recurrence score ≤10: Patients will have radiologic assessment of response to exemestane by clinical examination every 4 weeks and by radiologic assessment every 2 months. Once maximal response has been achieved (stable disease for 2 months after at least 4 months of treatment by radiologic assessment) or when 12 months of therapy has been given patients will proceed to surgery. Arm B: Patients will be assessed for surgery after 6 cycles of docetaxel and cytoxan (TC) (18 weeks). On arm A and recurrence score ≤10 patients will be reassessed for surgery once maximal radiologic response is achieved. On arm B, patients will be reassessed for surgery after 6 cycles of TC (18 weeks). Radiographic images were analyzed by a breast radiologist who looked at preoperative and postoperative breast mass imaging. If mass was smaller/less extensive, it was considered improved.
Outcome measures
| Measure |
A: Exemestane
n=15 Participants
ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months.
|
B: Docetaxel and Cytoxan
n=6 Participants
ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
|
|---|---|---|
|
Response Rate by Imaging
Improved
|
9 Participants
|
2 Participants
|
|
Response Rate by Imaging
Stable
|
6 Participants
|
4 Participants
|
Adverse Events
A: Exemestane
B: Docetaxel and Cytoxan
Serious adverse events
| Measure |
A: Exemestane
n=15 participants at risk
ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months.
|
B: Docetaxel and Cytoxan
n=11 participants at risk
ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis and Severe Diarrhea
|
0.00%
0/15
|
9.1%
1/11
|
Other adverse events
| Measure |
A: Exemestane
n=15 participants at risk
ARM A: Patients will be treated with exemestane.
Exemestane: 25 mg daily by mouth for 6 to 12 months.
|
B: Docetaxel and Cytoxan
n=11 participants at risk
ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
|
|---|---|---|
|
General disorders
Fever
|
6.7%
1/15
|
9.1%
1/11
|
|
Hepatobiliary disorders
Elevated Liver Enzymes
|
0.00%
0/15
|
9.1%
1/11
|
|
General disorders
Lower Extremity Edema
|
6.7%
1/15
|
18.2%
2/11
|
|
General disorders
Fatigue
|
46.7%
7/15
|
81.8%
9/11
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
13.3%
2/15
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
46.7%
7/15
|
18.2%
2/11
|
|
General disorders
Bloating
|
6.7%
1/15
|
0.00%
0/11
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
13.3%
2/15
|
18.2%
2/11
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.7%
1/15
|
0.00%
0/11
|
|
General disorders
Hot Flashes
|
53.3%
8/15
|
18.2%
2/11
|
|
General disorders
Headache
|
20.0%
3/15
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
3/15
|
9.1%
1/11
|
|
General disorders
Nausea
|
6.7%
1/15
|
18.2%
2/11
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Dry Mouth
|
6.7%
1/15
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15
|
0.00%
0/11
|
|
Psychiatric disorders
Anxiety
|
20.0%
3/15
|
0.00%
0/11
|
|
General disorders
Dizziness
|
6.7%
1/15
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Hypokalemia
|
6.7%
1/15
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Gait Disturbance
|
6.7%
1/15
|
0.00%
0/11
|
|
Renal and urinary disorders
Urinary Incontinence
|
6.7%
1/15
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Oral Mucositis
|
13.3%
2/15
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15
|
18.2%
2/11
|
|
Eye disorders
Floaters
|
6.7%
1/15
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Bruising
|
13.3%
2/15
|
0.00%
0/11
|
|
Psychiatric disorders
Depression
|
26.7%
4/15
|
9.1%
1/11
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/15
|
9.1%
1/11
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/15
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15
|
18.2%
2/11
|
|
General disorders
Insomnia
|
46.7%
7/15
|
27.3%
3/11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15
|
18.2%
2/11
|
|
Nervous system disorders
Memory Impairment
|
13.3%
2/15
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
13.3%
2/15
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15
|
18.2%
2/11
|
|
General disorders
Chest Pain
|
0.00%
0/15
|
9.1%
1/11
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
6.7%
1/15
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15
|
9.1%
1/11
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15
|
18.2%
2/11
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/15
|
18.2%
2/11
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
6.7%
1/15
|
9.1%
1/11
|
|
Nervous system disorders
Syncope
|
0.00%
0/15
|
9.1%
1/11
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15
|
0.00%
0/11
|
|
General disorders
Dysgeusia
|
0.00%
0/15
|
9.1%
1/11
|
|
Eye disorders
Watery Eyes
|
0.00%
0/15
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Weight Gain
|
6.7%
1/15
|
9.1%
1/11
|
|
General disorders
Chills
|
6.7%
1/15
|
0.00%
0/11
|
|
General disorders
Irritability
|
20.0%
3/15
|
9.1%
1/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place