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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01004081




Registration number
NCT01004081
Ethics application status
Date submitted
18/09/2009
Date registered
29/10/2009
Date last updated
2/10/2015

Titles & IDs
Public title
Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding
Scientific title
Phase 2a, Open-Label, Randomized, Noncomparative Study of BIIB021 in Combination With Exemestane in Women With Hormone Receptor-Positive, Advanced Metastatic Breast Cancer Who Have Progressed on a Nonsteroidal Aromatase Inhibitor
Secondary ID [1] 0 0
120BC201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIIB021
Treatment: Drugs - BIIB021
Treatment: Drugs - exemestane (Aromasin)

Experimental: BIIB021 BID + exemestane - BIIB021 100 mg BID + exemestane 25 mg QD

Experimental: BIIB021 TIW + exemestane - BIIB021 450 mg TIW + exemestane 25 mg QD


Treatment: Drugs: BIIB021
BID orally for 28 days

Treatment: Drugs: BIIB021
TIW orally for 28 days

Treatment: Drugs: exemestane (Aromasin)
Daily in tablet form for 28 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of this study is to assess the efficacy of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal AI.
Timepoint [1] 0 0
As specified in protocol
Secondary outcome [1] 0 0
The secondary objective of this study is to evaluate the safety and tolerability of BIIB021 in combination with exemestane in this study population.
Timepoint [1] 0 0
As specified in protocol

Eligibility
Key inclusion criteria
- Age 18 years of age

- Must have histologically or cytologically confirmed estrogen receptor- positive or
progesterone receptor-positive, incurable, locally advanced, or metastatic breast
cancer.

- Must have disease progression during treatment with a nonsteroidal AI for locally
advanced or metastatic disease, or relapse during treatment or within 12 months of
discontinuation of treatment in the adjuvant setting.

- Must be a postmenopausal female.

- Must have measurable or evaluable disease.

- Measurable disease is defined as >=1 lesion with a diameter of >=10 mm

- Evaluable disease is defined as bone lesions evaluable by plain X ray, CT scan,
or MRI. Lesions identified only by radionuclide bone scan are not allowed.

- One prior chemotherapy regimen for advanced mBC is allowed.

- Prior radiotherapy is allowed.

- Must be able to swallow and retain oral medication.

- ECOG performance status of <=2

- Required laboratory values

- Plasma cortisol and adrenocorticotropic hormone (ACTH) levels that are not
suggestive of adrenal insufficiency unless on replacement therapy for known
adrenal insufficiency.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- HER2 overexpressing tumor.

- History of central nervous system (CNS) metastasis.

- Previous treatment with exemestane or treatment with an Hsp90 inhibitor.

- Use of proton pump inhibitors.

- Known history of or positive test result for hepatitis B or C or HIV.

- History of gastrectomy or major surgery to small intestine.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Research Site - Waratah
Recruitment hospital [2] 0 0
Research Site - Wollongong
Recruitment hospital [3] 0 0
Research Site - Herston
Recruitment hospital [4] 0 0
Research Site - Redcliffe
Recruitment hospital [5] 0 0
Research Site - Hobart
Recruitment hospital [6] 0 0
Research Site - Geelong
Recruitment postcode(s) [1] 0 0
- Waratah
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Redcliffe
Recruitment postcode(s) [5] 0 0
- Hobart
Recruitment postcode(s) [6] 0 0
- Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Dakota
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Belgium
State/province [14] 0 0
Brasschaat
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Kortrijk
Country [17] 0 0
Belgium
State/province [17] 0 0
Liege
Country [18] 0 0
Belgium
State/province [18] 0 0
Mons
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Kuzmolovskiy
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Moscow
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Ryazan
Country [22] 0 0
Russian Federation
State/province [22] 0 0
St. Petersburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing
regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had
progressed following treatment with a nonsteroidal aromatase inhibitor (AI).
Trial website
https://clinicaltrials.gov/show/NCT01004081
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications