Breast CancerPhase 4SABRENCT00082277
Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
A Phase 4 study testing Anastrozole and Risedronate Sodium in people with Breast Cancer, run by AstraZeneca at 35 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy… Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole and Risedronate Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 35 sitesin 8 countries
- Study dates
- Apr 2004to Oct 2007
- Phase
- Phase 4
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women defined as Postmenopausal
- Histologically proven operable invasive breast cancer
- Hormone-receptor-positive breast cancer
Who cannot join
- Clinical evidence of metastatic disease
- Bilateral hip fractures or bilateral hip prosthesis
- Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens
- Malabsorption syndrome
Trial locations and contacts
35 sites in 8 countries.
35 sites in 8 countries
United States8 sites
Research Site
Cleveland, Ohio
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
New Orleans, Louisiana
Research Site
New York, New York
Research Site
Palm Springs, California
Research Site
Pittsburgh, Pennsylvania
Research Site
Raleigh, North Carolina
Canada5 sites
Research Site
Burnaby
Research Site
Edmonton
Research Site
Montreal
Research Site
Québec
Research Site
Vancouver
France5 sites
Research Site
Bordeaux
Research Site
Caen
Research Site
Lyon
Research Site
Saint-Cloud
Research Site
Saint-Herblain
Netherlands4 sites
Research Site
Goes
Research Site
Ijssel
Research Site
Nijmegen
Research Site
The Hague
Spain4 sites
Research Site
Pamplona
Research Site
Pontevedra
Research Site
Seville
Research Site
Valencia
United Kingdom4 sites
Research Site
Belfast
Research Site
Bolton
Research Site
Dundee
Research Site
Luton
South Africa3 sites
Research Site
Bloemfontain
Research Site
Cape Town
Research Site
Tygerberg
About this study
Official title: A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated
The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.
- Conditions
- Breast Cancer
- Being tested
- Anastrozole, Risedronate Sodium
- Keywords
- hormone-receptor positive, breast cancer, Osteopenia, Osteoporosis, risk of fracture, bone loss
- Medical subject headings
- Breast Neoplasms, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called ARIMIDEX™, ZD1033
1mg/Day Oral
Risedronate SodiumDrug
Also called ACTONEL™
35mg/week, oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum Receives: Drug: Anastrozole; Drug: Risedronate Sodium |
| 2 | Experimental | Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum Receives: Drug: Anastrozole; Drug: Risedronate Sodium |
| 3 | Experimental | Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum Receives: Drug: Anastrozole; Drug: Risedronate Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)
Measured: Assessed at 12 months
Secondary outcomes (6)
Change from baseline in total hip BMD
Measured: Assessed at 12 and 24 months
Change from baseline in lumbar spine (L1-L4) BMD
Measured: Assessed at 24 months
Change from baseline in bone formation markers
Measured: Assessed at 6 and12 months
Change from baseline in bone resorption and formation markers
Measured: Assessed at 6 and 12 months
Change from baseline in LDL-cholesterol
Measured: Assessed at 12 months
Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides
Measured: Assessed at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2004 (estimated)
- Study startApr 2004
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Arimidex Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082277
- Sponsor's protocol ID
- D5392C00050
- Other IDs
- SABRE
- Acronym
- SABRE
- Status last verified
- Jan 2011
- First submitted
- 5 May 2004
- Last updated
- 26 Jan 2011
- Results posted
- No
Publications
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PubMed 38979716
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated
- ClinicalTrials.gov ID
- NCT00082277
- Acronym / sponsor ID
- SABRE / D5392C00050
- Conditions
- Breast Cancer
- Keywords
- hormone-receptor positive, breast cancer, Osteopenia, Osteoporosis, risk of fracture, bone loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 6 May 2004 (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 evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Anastrozole, Drug: Risedronate SodiumHigh-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum |
| 2 | Experimental | Drug: Anastrozole, Drug: Risedronate SodiumModerate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum |
| 3 | Experimental | Drug: Anastrozole, Drug: Risedronate SodiumLow-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women defined as Postmenopausal
- Histologically proven operable invasive breast cancer
- Hormone-receptor-positive breast cancer
Key exclusion criteria (4 listed)
- Clinical evidence of metastatic disease
- Bilateral hip fractures or bilateral hip prosthesis
- Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens
- Malabsorption syndrome
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 |
|---|---|---|
| AnastrozoleAlso: ARIMIDEX™, ZD10331mg/Day Oral | Drug | 1, 2, 3 |
| Risedronate SodiumAlso: ACTONEL™35mg/week, oral | Drug | 1, 2, 3 |
Primary outcome
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)
Time frame: Assessed at 12 months
6 secondary outcomes
Change from baseline in total hip BMD
Time frame: Assessed at 12 and 24 months
Change from baseline in lumbar spine (L1-L4) BMD
Time frame: Assessed at 24 months
Change from baseline in bone formation markers
Time frame: Assessed at 6 and12 months
Change from baseline in bone resorption and formation markers
Time frame: Assessed at 6 and 12 months
Change from baseline in LDL-cholesterol
Time frame: Assessed at 12 months
Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides
Time frame: Assessed at 3, 6 and 12 months
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 26 Jan 2011.
- Derived from this study: PubMed 38979716Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
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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.
AstraZeneca Arimidex Medical Science Director, MD study director
AstraZeneca
35 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anastrozole and Risedronate Sodium in people with Breast Cancer, run by AstraZeneca at 35 sites in 8 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 3 inclusion and 4 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 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada, France, Netherlands, Spain and 3 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) (time frame: Assessed at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00082277, which also lists 1 linked publication.
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 26 Jan 2011.