Trial Outcomes & Findings for Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer. (NCT NCT00921115)
NCT ID: NCT00921115
Last Updated: 2023-05-19
Results Overview
Pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
4 months
Results posted on
2023-05-19
Participant Flow
Participant milestones
| Measure |
Arimidex + Faslodex
Patients will have an Oncotype Dx performed and if the RS is \<25, they will receive Anastrazole and Fulvestrant for 16 weeks.
On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer.
Baseline characteristics by cohort
| Measure |
Arimidex + Faslodex
n=42 Participants
Patients will have an Oncotype Dx performed and if the RS is \<25, they will receive Anastrazole and Fulvestrant for 16 weeks.
On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Number of participants with PCR after 4 cycles of Neoadjuvant Endocrine Therapy
Pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant).
Outcome measures
| Measure |
Arimidex + Faslodex
n=42 Participants
Patients will have an Oncotype Dx performed and if the RS is \<25, they will receive Anastrazole and Fulvestrant for 16 weeks.
On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles
|
|---|---|
|
Pathologic Complete Response (PCR) Rate
|
0 participants
|
Adverse Events
Arimidex + Faslodex
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arimidex + Faslodex
n=42 participants at risk
Patients will have an Oncotype Dx performed and if the RS is \<25, they will receive Anastrazole and Fulvestrant for 16 weeks.
On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.8%
2/42 • 4 months
|
|
Cardiac disorders
Valvular heart disease
|
2.4%
1/42 • 4 months
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • 4 months
|
Other adverse events
| Measure |
Arimidex + Faslodex
n=42 participants at risk
Patients will have an Oncotype Dx performed and if the RS is \<25, they will receive Anastrazole and Fulvestrant for 16 weeks.
On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • 4 months
|
|
Psychiatric disorders
Agitation
|
2.4%
1/42 • 4 months
|
|
Immune system disorders
Allergic reaction
|
7.1%
3/42 • 4 months
|
|
Psychiatric disorders
Anxiety
|
4.8%
2/42 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
9/42 • 4 months
|
|
Eye disorders
Blurred vision
|
2.4%
1/42 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
3/42 • 4 months
|
|
Reproductive system and breast disorders
Breast pain
|
11.9%
5/42 • 4 months
|
|
Infections and infestations
Bronchitis
|
2.4%
1/42 • 4 months
|
|
Skin and subcutaneous tissue disorders
Bruising
|
2.4%
1/42 • 4 months
|
|
Cardiac disorders
standard error of the mean systolic ejection murmur
|
2.4%
1/42 • 4 months
|
|
Cardiac disorders
Chest pain
|
4.8%
2/42 • 4 months
|
|
Gastrointestinal disorders
Constipation
|
19.0%
8/42 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.4%
1/42 • 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
4/42 • 4 months
|
|
Psychiatric disorders
Depression
|
11.9%
5/42 • 4 months
|
|
Skin and subcutaneous tissue disorders
change in hair texture
|
2.4%
1/42 • 4 months
|
|
Skin and subcutaneous tissue disorders
actinic keratosis
|
2.4%
1/42 • 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
2/42 • 4 months
|
|
Nervous system disorders
Dizziness
|
14.3%
6/42 • 4 months
|
|
Eye disorders
Dry eye syndrome
|
2.4%
1/42 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
3/42 • 4 months
|
|
General disorders
Edema limbs
|
7.1%
3/42 • 4 months
|
|
Endocrine disorders
worsening thyroid nodules requiring thyroidectomy
|
2.4%
1/42 • 4 months
|
|
Gastrointestinal disorders
Esophagitis
|
2.4%
1/42 • 4 months
|
|
General disorders
Fatigue
|
35.7%
15/42 • 4 months
|
|
General disorders
Fever
|
7.1%
3/42 • 4 months
|
|
Eye disorders
Flashing vision
|
2.4%
1/42 • 4 months
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
1/42 • 4 months
|
|
Infections and infestations
Gastric infection
|
2.4%
1/42 • 4 months
|
|
Nervous system disorders
Headache
|
9.5%
4/42 • 4 months
|
|
Gastrointestinal disorders
Heartburn
|
2.4%
1/42 • 4 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/42 • 4 months
|
|
Endocrine disorders
Hot flashes
|
50.0%
21/42 • 4 months
|
|
Cardiac disorders
Hypertension
|
2.4%
1/42 • 4 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.4%
1/42 • 4 months
|
|
Cardiac disorders
Hypotension
|
2.4%
1/42 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • 4 months
|
|
Infections and infestations
conjunctivitis
|
2.4%
1/42 • 4 months
|
|
Infections and infestations
Infection, Upper airway NOS
|
2.4%
1/42 • 4 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
7.1%
3/42 • 4 months
|
|
Psychiatric disorders
Insomnia
|
7.1%
3/42 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
40.5%
17/42 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
2.4%
1/42 • 4 months
|
|
Nervous system disorders
Memory impairment
|
2.4%
1/42 • 4 months
|
|
Metabolism and nutrition disorders
Low Vitamin D
|
4.8%
2/42 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.8%
2/42 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/42 • 4 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
7/42 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
4.8%
2/42 • 4 months
|
|
General disorders
Pain in extremity
|
7.1%
3/42 • 4 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.0%
8/42 • 4 months
|
|
Infections and infestations
Pharyngitis
|
2.4%
1/42 • 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • 4 months
|
|
Psychiatric disorders
Psychosis
|
2.4%
1/42 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
upper airway congestion
|
2.4%
1/42 • 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • 4 months
|
|
Infections and infestations
Rhinitis infective
|
2.4%
1/42 • 4 months
|
|
General disorders
Rigors/chills
|
7.1%
3/42 • 4 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
1/42 • 4 months
|
|
Infections and infestations
Sinusitis
|
2.4%
1/42 • 4 months
|
|
Skin and subcutaneous tissue disorders
Sweating
|
2.4%
1/42 • 4 months
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/42 • 4 months
|
|
Gastrointestinal disorders
Tooth disorder
|
2.4%
1/42 • 4 months
|
|
Nervous system disorders
Tremor
|
2.4%
1/42 • 4 months
|
|
Infections and infestations
Upper respiratory infection
|
4.8%
2/42 • 4 months
|
|
Renal and urinary disorders
Urinary frequency
|
2.4%
1/42 • 4 months
|
|
Renal and urinary disorders
Urinary incontinence
|
4.8%
2/42 • 4 months
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/42 • 4 months
|
|
Infections and infestations
Urinary tract infection
|
7.1%
3/42 • 4 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
2.4%
1/42 • 4 months
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
3/42 • 4 months
|
|
Investigations
Weight gain
|
7.1%
3/42 • 4 months
|
|
Investigations
Weight loss
|
4.8%
2/42 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place