An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

An observational study of Breast Neoplasms, run by Pfizer at 4 sites in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India. Efficacy of the treatment with Aromasin® Safety of the treatment with Aromasin® Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Breast Neoplasms
What is being tested?: Aromasin
How many people: 39 participants
Where: 4 sitesIndia
Study dates: Dec 2008to Sep 2012
Phase: Observational
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 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Study population: Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

Who may be able to join

Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

Who cannot join

Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included.
Patients with a known hypersensitivity to Exemestane or its metabolites will also not be included.

Trial locations and contacts

4 sites in 1 country.

India4 sites

Pfizer Investigational Site
Bangalore, Karnataka, 560 029
Pfizer Investigational Site
Lucknow, Uttar Pradesh, 226 001
Pfizer Investigational Site
Ludhiana, Punjab, 141 004
Pfizer Investigational Site
Ludhiana, Punjab, 141 009

Other trials in India

About this study

To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.

Efficacy of the treatment with Aromasin®
Safety of the treatment with Aromasin®

Read the detailed description

NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Conditions: Breast Neoplasms
Being tested: Aromasin
Keywords: An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin, Antineoplastic Hormonal Drugs, Aromasin
Medical subject headings: Breast Neoplasms

What participants receive

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

AromasinOther
Also called exemestane
Non-Interventional study design.

Study groups in NCT00776659
Study group	Role	What they receive
Observational		Not described Receives: Other: Aromasin

What is being measured

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

Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
Measured: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)
Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
Measured: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)
Number of Participants Who Died
Measured: Baseline until death (up to Year 3.5)
Number of Participants Who Discontinued Aromasin Therapy
Measured: Baseline until discontinuation (up to Year 3.5)
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.
Measured: Baseline up to 28 days after last dose of study treatment
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42
Measured: Baseline, Month 6, 12, 18, 24, 30, 36, 42
Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42
Measured: Baseline, Month 6, 12, 18, 24, 30, 36, 42

Timeline

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

Dec 2008Sep 2012

First posted21 Oct 2008 (estimated)
Study startDec 2008
Primary completionSep 2012
Study completionSep 2012

Why it stopped: See termination reason in detailed description.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00776659
Sponsor's protocol ID: A5991088
Status last verified: Sep 2013
First submitted: 20 Oct 2008
Last updated: 19 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
ClinicalTrials.gov ID: NCT00776659
Acronym / sponsor ID: A5991088
Conditions: Breast Neoplasms
Keywords: An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin, Antineoplastic Hormonal Drugs, Aromasin
Study type: Observational
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 39 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 21 Oct 2008 (estimated)
Results: Posted 19 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.

Efficacy of the treatment with Aromasin®
Safety of the treatment with Aromasin®

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational	–	Other: Aromasin

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

Key inclusion criteria (1 listed)

Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

Key exclusion criteria (2 listed)

Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included.
Patients with a known hypersensitivity to Exemestane or its metabolites will also not be included.

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
AromasinAlso: exemestaneNon-Interventional study design.	Other	Observational

Primary outcome

Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
Time frame: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)
Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
Time frame: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)
Number of Participants Who Died
Time frame: Baseline until death (up to Year 3.5)
Number of Participants Who Discontinued Aromasin Therapy
Time frame: Baseline until discontinuation (up to Year 3.5)
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
Time frame: Baseline up to 28 days after last dose of study treatment
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42
Time frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42
Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42
Time frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42

Results and safety

Results posted to the registry on 19 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exemestane	39	13

Primary outcome: Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer

Time frame: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5). Number. Unit: participants

Measure	Exemestane n = 7
Locoregional/Distant Recurrence	0
Missing/No response	1

Population analysed: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Primary outcome: Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer

Time frame: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5). Number. Unit: participants

Measure	Exemestane n = 7
Second primary or contralateral breast cancer	0
Missing/No response	1

Population analysed: FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Primary outcome: Number of Participants Who Died

Time frame: Baseline until death (up to Year 3.5). Number. Unit: participants

Measure	Exemestane n = 39
Value	0

Population analysed: FAS included all enrolled participants who received at least 1 dose of aromasin therapy.

Primary outcome: Number of Participants Who Discontinued Aromasin Therapy

Time frame: Baseline until discontinuation (up to Year 3.5). Number. Unit: participants

Measure	Exemestane n = 39
Value	26

Population analysed: FAS included all enrolled participants who received at least 1 dose of aromasin therapy.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exemestane	0 of 39 (0%)	10 of 39 (25.6%)	Not reported

Limitations and caveats (from the sponsor): Study was terminated due to slow enrollment and observational nature of the study. Low number of participants enrolled was not sufficient to conduct the planned analysis. Study was not terminated due to safety concerns.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Pfizer at 4 sites in India.

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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2013). 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 With Locoregional/Distant Recurrence of Primary Breast Cancer (time frame: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)). The study lists 7 primary outcomes in all. 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 NCT00776659.

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 19 Nov 2013.