Trial Outcomes & Findings for Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy (NCT NCT00570258)

Last Updated: 2021-03-30

Results Overview

This will be defined as the date from randomization onset to first documented occurrence of PD. Death will be regarded as a progression event in those subjects who die before disease progression. Subjects without documented objective progression at the time of the final analysis will be censored at the date of their last tumor assessment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

through study completion, an average of 3 years

Results posted on

2021-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Fulvestrant Plus Placebo Fulvestrant: 250 mg IM Q 4 weeks Placebo: 150 mg PO QD Fulvestrant: 250 mg IM Q 4 weeks Placebo: Placebo 150 mg PO QD	Fulvestrant Plus Erlotinib Fulvestrant: 250 mg IM Q 4 weeks Erlotinib: 150 mg PO QD Fulvestrant: Fulvestrant: 250 mg IM Q 4 weeks erlotinib: 150 mg PO QD
Overall Study STARTED	12	15
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	12	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fulvestrant Plus Placebo n=12 Participants Fulvestrant: 250 mg IM Q 4 weeks Placebo: 150 mg PO QD Fulvestrant: 250 mg IM Q 4 weeks Placebo: Placebo 150 mg PO QD	Fulvestrant Plus Erlotnib n=15 Participants Fulvestrant: 250 mg IM Q 4 weeks Erlotinib: 150 mg PO QD Fulvestrant: Fulvestrant: 250 mg IM Q 4 weeks erlotinib: 150 mg PO QD	Total n=27 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	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 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	12 participants n=5 Participants	15 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 3 years

Population: Early termination due to a change in drug FDA approval. No subject completed study. No data analysis was completed. No data collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion, an average of 3 years

Population: Early termination due to a change in drug FDA approval. Outcome measures not computed on collected data because data would not be statistically relevant. No data analysis was completed. No data collected.

evaluate response rate and the clinical benefit of fulvestrant alone or in combination with erlotinib

Outcome measures

Outcome data not reported

Adverse Events

Fulvestrant Plus Placebo

Serious events: 2 serious events

Other events: 3 other events

Deaths: 8 deaths

Fulvestrant Plus Erlotinib

Serious events: 3 serious events

Other events: 5 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Fulvestrant Plus Placebo n=12 participants at risk Fulvestrant: 250 mg IM Q 4 weeks Placebo: 150 mg PO QD Fulvestrant: 250 mg IM Q 4 weeks Placebo: Placebo 150 mg PO QD	Fulvestrant Plus Erlotinib n=15 participants at risk Fulvestrant: 250 mg IM Q 4 weeks Erlotinib: 150 mg PO QD Fulvestrant: Fulvestrant: 250 mg IM Q 4 weeks erlotinib: 150 mg PO QD
Respiratory, thoracic and mediastinal disorders shortness of breath	8.3% 1/12 • Number of events 1 • 5 years	13.3% 2/15 • Number of events 2 • 5 years
Immune system disorders fever of unknown origin	0.00% 0/12 • 5 years	6.7% 1/15 • Number of events 1 • 5 years
Cardiac disorders possible heart failure	8.3% 1/12 • Number of events 1 • 5 years	0.00% 0/15 • 5 years
Respiratory, thoracic and mediastinal disorders pulmonary embolus	0.00% 0/12 • 5 years	6.7% 1/15 • Number of events 1 • 5 years
Cardiac disorders hypotension	0.00% 0/12 • 5 years	6.7% 1/15 • Number of events 1 • 5 years

Other adverse events

Other adverse events
Measure	Fulvestrant Plus Placebo n=12 participants at risk Fulvestrant: 250 mg IM Q 4 weeks Placebo: 150 mg PO QD Fulvestrant: 250 mg IM Q 4 weeks Placebo: Placebo 150 mg PO QD	Fulvestrant Plus Erlotinib n=15 participants at risk Fulvestrant: 250 mg IM Q 4 weeks Erlotinib: 150 mg PO QD Fulvestrant: Fulvestrant: 250 mg IM Q 4 weeks erlotinib: 150 mg PO QD
General disorders anorexia	8.3% 1/12 • Number of events 1 • 5 years	6.7% 1/15 • Number of events 2 • 5 years
General disorders alopecia	8.3% 1/12 • Number of events 1 • 5 years	6.7% 1/15 • Number of events 1 • 5 years
Gastrointestinal disorders diarrhea	0.00% 0/12 • 5 years	26.7% 4/15 • Number of events 4 • 5 years
Skin and subcutaneous tissue disorders dry skin	0.00% 0/12 • 5 years	13.3% 2/15 • Number of events 2 • 5 years
Skin and subcutaneous tissue disorders rash	8.3% 1/12 • Number of events 1 • 5 years	20.0% 3/15 • Number of events 6 • 5 years
General disorders fatigue	8.3% 1/12 • Number of events 1 • 5 years	13.3% 2/15 • Number of events 5 • 5 years
Gastrointestinal disorders nausea/vomiting	0.00% 0/12 • 5 years	13.3% 2/15 • Number of events 7 • 5 years
General disorders pain	8.3% 1/12 • Number of events 1 • 5 years	33.3% 5/15 • Number of events 5 • 5 years
General disorders dizziness	8.3% 1/12 • Number of events 1 • 5 years	0.00% 0/15 • 5 years
General disorders cough	8.3% 1/12 • Number of events 1 • 5 years	0.00% 0/15 • 5 years
Gastrointestinal disorders bloating	8.3% 1/12 • Number of events 1 • 5 years	0.00% 0/15 • 5 years
General disorders pruritis	0.00% 0/12 • 5 years	6.7% 1/15 • Number of events 1 • 5 years
General disorders dyspnea	8.3% 1/12 • Number of events 1 • 5 years	0.00% 0/15 • 5 years

Additional Information

Beth Scanlan

University of Arkansas for Medical Sciences

Phone: 501-686-8274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place