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AzTrials

Breast CancerPhase 3NCT00354302

Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial

A Phase 3 study testing calcium carbonate, calcium citrate and cholecalciferol in people with Breast Cancer and Osteoporosis, run by NCIC Clinical Trials Group at 13 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably. Read more about this study

Who is it for?
Ages 45 to 120 years, women only
Conditions the study is for
Breast Cancer, Osteoporosis
What is being tested?
calcium carbonate, calcium citrate and cholecalciferol
Type of treatment
Surgery or procedure
How many people
497 participants
Where
13 sitesCanada
Study dates
24 Apr 2006to 6 Jan 2012
Phase
Phase 3
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 45 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Enrolled in and meets eligibility requirements for protocol CAN-NCIC-MA27
  • Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L1-L4 postero-anterior spine and hip within 12 weeks prior to randomization on protocol CAN-NCIC-MA27
  • Hormone receptor status:
  • Estrogen receptor- and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

  • Female
  • Postmenopausal
  • No malabsorption syndrome
  • No known cholecalciferol (vitamin D) deficiency, active hyper- or hypoparathyroidism, or Paget's disease
  • No uncontrolled thyroid disease, Cushing's disease, or other pituitary disease
  • No other bone disease (including osteomalacia or osteogenesis imperfecta)

PRIOR CONCURRENT THERAPY:

  • More than 6 months since prior drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (stratum I)
  • More than 12 months since prior and no concurrent anticonvulsants
  • More than 6 months since prior and no concurrent corticosteroids at doses > 5 mg/day of prednisone (or equivalent) for > 2 weeks
  • More than 12 months since prior and no concurrent anabolic steroids
  • No prior bisphosphonates (stratum II)
  • No concurrent sodium fluoride at daily doses ≥ 5 mg/day
  • No long-term (i.e., > 6 months) use of coumarins
  • No concurrent drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (for patients with no osteopenia or osteoporosis [stratum I])

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Canada13 sites

  • Cambridge Memorial Hospital

    Cambridge, Ontario, N1R 3G2

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2

  • Algoma District Cancer Program

    Sault Ste. Marie, Ontario, P6B 0A8

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer

RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably.

PURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.

Read the detailed description

OBJECTIVES:

  • Determine whether there is a clinically relevant difference in bone mineral density (BMD) at 2 years in postmenopausal women with primary breast cancer (with or without osteopenia or osteoporosis) treated with exemestane vs anastrozole on protocol CAN-NCIC-MA27.

OUTLINE: This is a multicenter, companion study. Patients are stratified according to baseline bone mineral density (BMD) measurement (T-score* ≥ -2.0 standard deviation [SD] [no osteopenia or osteoporosis] vs T-score* < -2.0 SD).

NOTE: *The lowest of the two T-scores: L1-L4 or total hip

Blood samples for the identification of bone biomarkers (formation marker: serum amino-terminal procollagen 1 extension peptide [P1NP] and resorption marker: serum N-telopeptide) are obtained at baseline and at 6 and 12 months. BMD is determined by dual-energy x-ray absorptiometry (DEXA) at baseline and then annually for 5 years (or for as long as patient is receiving treatment on protocol CAN-NCIC-MA27).

Patients receive oral calcium and oral cholecalciferol (vitamin D) daily. Patients with osteopenia or osteoporosis (stratum II) also receive oral bisphosphonate therapy

PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.

Being tested
calcium carbonate, calcium citrate, cholecalciferol, alendronate sodium, calcium gluconate
Keywords
osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Medical subject headings
Breast Neoplasms, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • calcium carbonateDietary supplement

  • calcium citrateDietary supplement

  • cholecalciferolDietary supplement

  • alendronate sodiumDrug

  • calcium gluconateDrug

  • risedronate sodiumDrug

  • laboratory biomarker analysisOther

  • dual x-ray absorptometryProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip

    Measured: 5 years

Secondary outcomes (6)

  1. Percentage change in BMD at 5 years (from baseline)

    Measured: 5 years

  2. Mean percentage change in BMD at 1, 3, and 5 years (from baseline)

    Measured: 5 years

  3. Proportion of patients without osteopenia or osteoporosis (stratum I) who develop BMD below the absolute threshold for osteopenia (< -2.0 standard deviation below the mean), suffer any osteoporotic fracture, or have an asymptomatic fracture revealed ...

    Measured: 5 years

  4. Percentage of patients with osteopenia or osteoporosis (stratum II) who have ≥ 5% improvement of BMD at 2 years post randomization on protocol CAN-NCIC-MA27 and who have clinically apparent osteoporosis-related fracture of the long bones

    Measured: 5 years

  5. Pattern of change in bone biomarkers from baseline

    Measured: 5 years

  6. Clinical safety and tolerability of study medications

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2006 (estimated)
  2. Study start24 Apr 2006
  3. Primary completionMar 2011
  4. Study completion6 Jan 2012

Resources

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 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
497 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00354302
Sponsor's protocol ID
MA27B
Other IDs
CAN-NCIC-MA27B, SWOG-NCIC-MA27B, NCCTG-NCIC-MA27B, CAN-NCIC-BONE, CDR0000483099
Status last verified
Jan 2012
First submitted
19 Jul 2006
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Goss PE, Hershman DL, Cheung AM, Ingle JN, Khosla S, Stearns V, Chalchal H, Rowland K, Muss HB, Linden HM, Scher J, Pritchard KI, Elliott CR, Badovinac-Crnjevic T, St Louis J, Chapman JA, Shepherd LE. Effects of adjuvant exemestane versus anastrozole on bone mineral density for women with early breast cancer (MA.27B): a companion analysis of a randomised controlled trial. Lancet Oncol. 2014 Apr;15(4):474-82. doi: 10.1016/S1470-2045(14)70035-X. Epub 2014 Mar 11.

    PubMed 24636210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing calcium carbonate, calcium citrate and cholecalciferol in people with Breast Cancer and Osteoporosis, run by NCIC Clinical Trials Group at 13 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip (time frame: 5 years). 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 NCT00354302, 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 2 Apr 2020.

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