Trial Outcomes & Findings for Estrogen for Triple Negative Breast Cancer (NCT NCT01083641)

Last Updated: 2019-12-09

Results Overview

OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Up to 4 years

Results posted on

2019-12-09

Participant Flow

This multicenter phase 2 study was conducted through the Wisconsin Oncology Network. Subjects were recruited from February 2010 through March 2013.

Participant milestones

Participant milestones
Measure	Estrogen Therapy Estrogen therapy Estradiol: 10mg oral three times daily
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Estrogen Therapy Estrogen therapy Estradiol: 10mg oral three times daily
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Estrogen for Triple Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Estrogen Therapy n=17 Participants Estrogen therapy Estradiol: 10mg oral three times daily
Age, Continuous	57.9 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Stage at Diagnosis Stage I	3 Participants n=5 Participants
Stage at Diagnosis Stage II	9 Participants n=5 Participants
Stage at Diagnosis Stage III	4 Participants n=5 Participants
Stage at Diagnosis Stage IV	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Outcome measures

Outcome measures
Measure	Estrogen Therapy n=15 Participants Estrogen therapy Estradiol: 10mg oral three times daily
Determine Tumor Objective Response (OR) Rates	5.9 percentage of participants Interval 0.2 to 28.7

SECONDARY outcome

Timeframe: Up to 4 years

Defined as complete response, partial response, or stable disease at \> 16 weeks

Outcome measures

Outcome measures
Measure	Estrogen Therapy n=17 Participants Estrogen therapy Estradiol: 10mg oral three times daily
Clinical Benefit (CB) Complete Response	0 Participants
Clinical Benefit (CB) Partial Response	1 Participants
Clinical Benefit (CB) Stable Disease at > 16 weeks	1 Participants
Clinical Benefit (CB) Stable Disease < 16 weeks	2 Participants

SECONDARY outcome

Timeframe: Up to 4 years

Outcome measures

Outcome measures
Measure	Estrogen Therapy n=17 Participants Estrogen therapy Estradiol: 10mg oral three times daily
Progression-free Survival (PFS)	1.9 months Interval 1.3 to 4.0

SECONDARY outcome

Timeframe: Up to 4 years

Outcome measures

Outcome measures
Measure	Estrogen Therapy n=17 Participants Estrogen therapy Estradiol: 10mg oral three times daily
Median Overall Survival (OS)	7.6 months Interval 3.9 to 20.4

Adverse Events

Estrogen Therapy

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Estrogen Therapy n=17 participants at risk Estrogen therapy Estradiol: 10mg oral three times daily
Gastrointestinal disorders Vomiting	11.8% 2/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Nervous system disorders Headache	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Blood and lymphatic system disorders Hemorrhage	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Infections and infestations Infection	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Musculoskeletal and connective tissue disorders Muscle weakness	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Musculoskeletal and connective tissue disorders Pain- back	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Nervous system disorders Seizure	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Cardiac disorders Supraventricular and nodal arrhythmia	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Vascular disorders Thrombosis/Thrombus/embolism	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Nervous system disorders Dizziness	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 2/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
General disorders Fatigue	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
General disorders Fever	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.

Other adverse events

Other adverse events
Measure	Estrogen Therapy n=17 participants at risk Estrogen therapy Estradiol: 10mg oral three times daily
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia) Count	58.8% 10/17 • Number of events 11 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Metabolism and nutrition disorders Alkaline phosphatase Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase) Count	11.8% 2/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Gastrointestinal disorders Anorexia Count	23.5% 4/17 • Number of events 4 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase) Count	17.6% 3/17 • Number of events 5 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia) Count	17.6% 3/17 • Number of events 4 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Nervous system disorders Confusion Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Gastrointestinal disorders Constipation Count	23.5% 4/17 • Number of events 5 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Respiratory, thoracic and mediastinal disorders Cough Count	29.4% 5/17 • Number of events 5 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Metabolism and nutrition disorders Creatinine Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Skin and subcutaneous tissue disorders Dermal change lymphedema, phlebolymphedema Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Skin and subcutaneous tissue disorders Dermatology/Skin Count	5.9% 1/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Gastrointestinal disorders Diarrhea Count	5.9% 1/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Gastrointestinal disorders Distension/bloating, abdominal Count	17.6% 3/17 • Number of events 3 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Nervous system disorders Dizziness Count	17.6% 3/17 • Number of events 3 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia) Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath) Count	29.4% 5/17 • Number of events 5 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Blood and lymphatic system disorders Edema: limb Count	35.3% 6/17 • Number of events 7 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
General disorders Fatigue (asthenia, lethargy, malaise) Count	76.5% 13/17 • Number of events 23 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia) Count	17.6% 3/17 • Number of events 3 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia) Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body) Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Blood and lymphatic system disorders Hemoglobin Count	35.3% 6/17 • Number of events 7 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Blood and lymphatic system disorders Hemorrhage Count	29.4% 5/17 • Number of events 7 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Cardiac disorders Hypertension Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Infections and infestations Infection Count	23.5% 4/17 • Number of events 4 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Blood and lymphatic system disorders Leukocytes (total WBC) Count	17.6% 3/17 • Number of events 5 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Blood and lymphatic system disorders Lymphedema-related fibrosis Count	11.8% 2/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Blood and lymphatic system disorders Lymphopenia Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Nervous system disorders Mood alteration - Anxiety Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Nervous system disorders Mood alteration - Depression Count	11.8% 2/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Gastrointestinal disorders Nausea Count	64.7% 11/17 • Number of events 12 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Nervous system disorders Neuropathy: sensory Count	35.3% 6/17 • Number of events 8 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC) Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
General disorders Pain Count	82.4% 14/17 • Number of events 26 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia) Count	11.8% 2/17 • Number of events 4 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Skin and subcutaneous tissue disorders Pruritus/itching Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other (Specify, __) Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia) Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Reproductive system and breast disorders Vaginal discharge (non-infectious) Count	23.5% 4/17 • Number of events 4 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Eye disorders Vision-flashing lights/floaters Count	5.9% 1/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) Count	5.9% 1/17 • Number of events 1 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
Gastrointestinal disorders Vomiting Count	29.4% 5/17 • Number of events 5 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
General disorders Weight gain Count	11.8% 2/17 • Number of events 2 • Adverse event data was collected for 4 years. Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.

Additional Information

Dr. Kari Wisinski

University of Wisconsin Carbone Cancer Center

Phone: 608-262-2876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place