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Breast CancerPhase 4REALNCT00688909

Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer

A Phase 4 study testing letrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 48 sites in United States.

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

This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
48 sitesUnited States
Study dates
Mar 2008to Jun 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Postmenopausal women with HR+ early stage breast cancer at the time of initial diagnosis. For study purposes, postmenopausal is defined as:
  • Age ≥ 50 y and amenorrheic for 12 or more months.
  • Age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy.
  • Age < 50 y and amenorrheic for 12 or more months.
  • Prior bilateral oophorectomy.
  • Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as per local institutional standards.
Show all 11Show fewer
  • Age > 55 y and prior hysterectomy.
  • Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for HR+ early stage breast cancer due to grade 2-3 (NCI-CTCAE V3) arthralgia-myalgia.
  • Hormone receptor-positive tumors as defined by institutional standards.
  • ECOG performance status of 0, 1, or 2
  • Consent to participate in the trial. -

Who cannot join

  • Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.
  • Recent history of pain associated with non-traumatic bone fracture.
  • Pain requiring chronic use of analgesics (due to any reason).
  • History of rheumatological disease except osteoarthritis.
  • Prior hormonal therapy with AIs other than anastrozole.
  • Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other than Estring®, Vagifem® or low dose estrogen vaginal cream.
Show all 10Show fewer
  • Concomitant disease which significantly affects quality of life.
  • Patient unable to complete self administered questionnaire.
  • Patients unable to sign consent form.
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • Summa Health System

    Akron, Ohio, 44304

  • Central Utah Clinic

    American Fork, Utah, 84003

  • Cancer Care of W. NC

    Asheville, North Carolina, 28801

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Augusta Oncology

    Augusta, Georgia, 30901

  • Mercey Hospital

    Baltimore, Maryland, 21202

  • Maryland Hematology Oncology Associates, PA

    Baltimore, Maryland, 21237

  • Suburban Hospital Cancer Program

    Bethesda, Maryland, 20817

  • Broom Oncology

    Binghamton, New York, 13905

  • Lynn Cancer Center

    Boca Raton, Florida, 33428

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78404

  • Center for Oncology Research and Treatment

    Dallas, Texas, 75230

  • Trinitas Comprehensive Cancer Center

    Elizabeth, New Jersey, 07207

  • The Cancer Instiute at Alexian Brothers

    Elk Grove Village, Illinois, 60007

  • Evanston Northwestern Hospital

    Evanston, Illinois, 60201

  • Medical Oncology & Hematology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Front Range Specialist

    Fort Collins, Colorado, 80528

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Oncology Specialist of North Georgia

    Gainesville, Georgia, 30501

  • Grass Valley Hematology Oncology

    Grass Valley, California, 95945

  • Green Bay Oncologist, St Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Rockingham Memorial Hospital Regional Cancer Center

    Harrisonburg, Virginia, 22801

  • Memorial Cancer Center

    Hollywood, Florida, 33021

  • Clearview Cancer Center

    Huntsville, Alabama, 35805

  • Hematology Oncology Asssociates of Ohio & Michigan

    Lambertville, Michigan, 48144

  • Southeast Nebraska Hematology & Oncology Consultants

    Lincoln, Nebraska, 68516

  • Hematology Oncology Services of Arkansas

    Little Rock, Arkansas, 72205

  • Kentuckiana Cancer Institute

    Louisville, Kentucky, 40202

  • Mukesh Bhatt, MD, INC.

    Medina, Ohio, 44256

  • The West Clinic

    Memphis, Tennessee, 38138

  • Hematology-Oncology Assoc of Northern New Jersey

    Morristown, New Jersey, 07962

  • Tenessee Oncology

    Nashville, Tennessee, 37203

  • Peninsula Cancer Center

    Newport News, Virginia, 23601

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Aptium Oncology - Comprehensive Cancer Care of the Desert

    Palm Springs, California, 92262

  • Bay Area Cancer Research Group

    Pleasant Hill, California, 94523

  • Mercy Hospital

    Portland, Maine, 04101

  • Edward H. Kaplan MD & Associates - North Shore Cancer Research Associates

    Skokie, Illinois, 60076

  • Somerset Hematology & Oncology

    Somerville, New Jersey, 08876

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Ballas Cancer Center, LLC DBA - St Louis

    St Louis, Missouri, 63414

  • Cooper University Hospital

    Voorhees Township, New Jersey, 08043

  • Marion L. Shepard Cancer Center

    Washington, North Carolina, 27889

  • Oncology Alliance

    Wauwatosa, Wisconsin, 53226

  • Palm Beach Cancer Specialists

    West Palm Beach, Florida, 33401

  • Berks Hematology Oncology

    West Reading, Pennsylvania, 19611

  • Cancer Care of Kansas

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Open-label, Single-arm, Multicenter Study to Evaluate the Rheumatological Tolerability of Letrozole as an Adjuvant Breast Cancer Treatment in Postmenopausal Women Who Are Intolerant and Discontinue Anastrozole Due to Grade 2-3 Arthralgia-myalgia

This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole

Read the detailed description

This is a multi-center prospective non-randomized single arm, open label trial in postmenopausal HR positive early breast cancer patients who experience grade 2-3 arthralgia-myalgia while on anastrozole, resulting in the discontinuation of anastrozole. After a 2-3 week period without any aromatase inhibitor treatment, eligible patients will initiate letrozole treatment at a dose of 2.5mg per day for a duration of 24 weeks. If a patient has breast cancer recurrence or is intolerant to letrozole during the 24 week period, the drug will be discontinued.

Conditions
Breast Cancer
Being tested
letrozole
Keywords
breast cancer, adjuvant treatment in post menopausal women, letrozole, arthralgia-myalgia
Medical subject headings
Breast Neoplasms

What participants receive

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

  • letrozoleDrug

    Also called Femara

    2.5 mg daily by mouth for 6 months

Study groups in NCT00688909
Study groupRoleWhat they receive
LetrozoleExperimentalParticipants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
Receives: Drug: letrozole

What is being measured

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

  1. Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia.

    The arthralgia status and the myalgia status were separately graded at Baseline (V1), Week 12 (V3) , and Week 24/EOS (V4). The grades of 0 for no pain, 1 for mild pain, 2 for moderate pain, 3 for severe pain, and 4 for disabling pain were used.

    Measured: End of Study (24 weeks)

Secondary outcomes (5)

  1. Time to Discontinuation Due to Grade 2 or Higher Arthralgia- Myalgia.

    For patients who discontinued from the study due to either grade 2 or higher arthralgia-myalgia, the time to discontinuation was calculated as the duration between the Visit 1 date and the last dose date. If the last dose date was missing, the EOS date was used.

    Measured: End of Study (24 weeks)

  2. Percentage of Participants Discontinuing, Irrespective of Cause

    The percentage of patients who discontinued from the study irrespective of the reasons.

    Measured: End of Study (24 weeks)

  3. Change in Brief Pain Inventory (BPI) Composite Score

    The BPI is a pain assessment tool for use with cancer patients. The BPI measures both the intensity of pain (sensory dimension) and interference of pain in the patient's life (reactive dimension). It also queries the patient about pain relief, pain quality, and patient perception of the cause of pain. The BPI composite score was calculated based on questions 3 to 6 of the BPI Questionnaire (short form). First each question was scored from 0 (no pain) to 10 (pain as bad as you can imagine) and circled on the CRF. Then a composite score was calculated as the mean of the scores. If any answer was missing, the composite score was set to missing. Change in BPI composite score indicates the change from baseline at week 24.

    Measured: Baseline, 24 weeks (End of Study)

  4. Change in Disability Index as Assessed by Health Assessment Questionnaire (HAQ)

    The HAQ is a validated, patient-oriented outcome assessment instrument. The short version '2 page HAQ' was used. It contains the HAQ Disability Index (HAQ-DI), the HAQ visual analog scale (VAS) for pain and the VAS patient global health scale. The Stanford HAQ 20-item disability scale was utilized for scoring of the Disability Index. The items were first scored within each category with values 0 to 3 (0 = Without any difficulty, 1 = With some difficulty, 2 = With much difficulty, 3 = Unable to do). The score for the disability index was the mean of the eight category scores. If more than 2 of the 8 categories, or >25%, were missing, the scale was not scored. If ≤2 of the categories were missing, the sum of the categories was divided by the number of answered categories. Change in Disability Index indicates the change from baseline at week 24.

    Measured: Baseline, Visit 1(24 weeks = End of Study)

  5. Change in Pain as Assessed by Visual Analog Scale (VAS) Scale of the Health Assessment Questionnaire (HAQ)

    The HAQ is a validated, patient-oriented outcome assessment instrument. The short version '2 page HAQ' was used. It contains the HAQ Disability Index (HAQ-DI), the HAQ visual analog scale (VAS) for pain and the VAS patient global health scale. The VAS is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). A higher score indicates greater pain intensity. Change in pain as assessed by VAS indicates the change from baseline at week 24.

    Measured: Baseline, Visit 1 (24 weeks = End of Study)

Timeline

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

  1. First posted3 Jun 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

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 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00688909
Sponsor's protocol ID
CFEM345DUS59
Acronym
REAL
Status last verified
May 2021
First submitted
29 May 2008
Last updated
9 Jun 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing letrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 48 sites in United States.

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 11 inclusion and 10 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 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. 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?

Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Discontinuing Due to Grade 2 or Higher Arthralgia-myalgia. (time frame: End of Study (24 weeks)). 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 NCT00688909.

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 9 Jun 2021.

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