Breast CancerPhase 2NCT01004081
Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding
A Phase 2 study testing BIIB021 and exemestane (Aromasin) in people with Breast Cancer, run by Biogen at 34 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BIIB021 and exemestane (Aromasin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 34 sitesin 4 countries
- Study dates
- Nov 2009to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
United States19 sites
Research Site
Alabaster, Alabama
Research Site
Berkeley Heights, New Jersey
Research Site
Columbus, Ohio
Research Site
Davie, Florida
Research Site
El Paso, Texas
Research Site
Encinitas, California, 92024
Research Site
Encinitas, California
Research Site
Fargo, North Dakota
Research Site
Gilroy, California
Research Site
Houston, Texas
Research Site
Lacey, Washington
Research Site
Long Beach, California
Research Site
Nashville, Tennessee
Research Site
New York, New York
Research Site
Orlando, Florida
Research Site
Pittsburgh, Pennsylvania
Research Site
Rochester, Minnesota
Research Site
San Antonio, Texas, 78229
Research Site
St Louis, Missouri
Australia6 sites
Research Site
Geelong, Victoria
Research Site
Herston, Queensland
Research Site
Hobart, Tasmania
Research Site
Redcliffe, Queensland
Research Site
Waratah, New South Wales
Research Site
Wollongong, New South Wales
Belgium5 sites
Research Site
Brasschaat
Research Site
Edegem
Research Site
Kortrijk
Research Site
Liège
Research Site
Mons
Russia4 sites
Research Site
Kuzmolovskiy
Research Site
Moscow
Research Site
Ryazan
Research Site
Saint Petersburg
About this study
Official 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
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).
- Conditions
- Breast Cancer
- Being tested
- BIIB021, exemestane (Aromasin)
- Keywords
- Cancer of Breast, Cancer of the Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB021Drug
Also called CNF2024
BID orally for 28 days
BIIB021Drug
Also called CNF2024
TIW orally for 28 days
exemestane (Aromasin)Drug
Also called Aromasin
Daily in tablet form for 28 days
| Study group | Role | What they receive |
|---|---|---|
| BIIB021 BID + exemestane | Experimental | BIIB021 100 mg BID + exemestane 25 mg QD Receives: Drug: BIIB021; Drug: exemestane (Aromasin) |
| BIIB021 TIW + exemestane | Experimental | BIIB021 450 mg TIW + exemestane 25 mg QD Receives: Drug: BIIB021; Drug: exemestane (Aromasin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: As specified in protocol
Secondary outcomes (1)
The secondary objective of this study is to evaluate the safety and tolerability of BIIB021 in combination with exemestane in this study population.
Measured: As specified in protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004081
- Sponsor's protocol ID
- 120BC201
- Status last verified
- Dec 2011
- First submitted
- 18 Sep 2009
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01004081
- Acronym / sponsor ID
- 120BC201
- Conditions
- Breast Cancer
- Keywords
- Cancer of Breast, Cancer of the Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIB021 BID + exemestane | Experimental | Drug: BIIB021, Drug: exemestane (Aromasin)BIIB021 100 mg BID + exemestane 25 mg QD |
| BIIB021 TIW + exemestane | Experimental | Drug: BIIB021, Drug: exemestane (Aromasin)BIIB021 450 mg TIW + exemestane 25 mg QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIIB021Also: CNF2024BID orally for 28 days | Drug | BIIB021 BID + exemestane |
| BIIB021Also: CNF2024TIW orally for 28 days | Drug | BIIB021 TIW + exemestane |
| exemestane (Aromasin)Also: AromasinDaily in tablet form for 28 days | Drug | BIIB021 BID + exemestane, BIIB021 TIW + exemestane |
Primary outcome
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.
Time frame: As specified in protocol
1 secondary outcome
The secondary objective of this study is to evaluate the safety and tolerability of BIIB021 in combination with exemestane in this study population.
Time frame: As specified in protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB021 and exemestane (Aromasin) in people with Breast Cancer, run by Biogen at 34 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Australia, Belgium, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: As specified in protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.