Benign Breast DiseasePhase 4NCT00999921

Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer

A Phase 4 study testing Tamoxifen and Evening Primrose Oil in people with Benign Breast Disease and Fibrocystic Disease of Breast, run by Medical College and Hospital Kolkata at 1 site in India.

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

The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiology and estrogen receptor status and to realize its side-effects and cost of therapy. Read more about this study

Who is it for?: Ages 16 years and older, women only
Conditions the study is for: Benign Breast Disease, Fibrocystic Disease of Breast, Fibroadenoma
What is being tested?: Tamoxifen and Evening Primrose Oil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 256 participants
Where: 1 siteIndia
Study dates: Jan 2008to Jan 2015
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 16 years and older
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.
Benign Breast disease amenable to hormonal therapy.

Who cannot join

Postmenopausal women.
Premenopausal women with pregnancy or other contraindications to tamoxifen.
Girls less than 16 years.
Very large lesions which require surgery for cosmesis.
High risk breast lesions like epitheliosis, atypia or atypical hyperplasia on histopathology or susceptible lesions prone to develop malignancy.
Lesions like duct ectasia where hormone therapy is not likely to be of benefit.
Inflammatory lesions which are amenable to antibiotic therapy or surgical drainage for treatment.
Patients unwilling to undergo treatment.

Trial locations and contacts

1 site in 1 country.

India1 site

Department of Surgery, Medical College, Kolkata
Kolkata, West Bengal, 700073

Other trials in India

About this study

Official title: A Single Blinded Randomized Controlled Trial of the Comparative Effects of Tamoxifen and Evening Primrose Oil in Premenopausal Non-high Risk Patients With Benign Breast Disease With Respect to the Estrogen Receptor Status.

To do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.

Read the detailed description

Benign breast disease is frequently encountered in female patients, a significant proportion of who are premenopausal women. Established methods of treatment do not yield significant results. This is not only a social burden but also entails high economic cost. As such the quality of life of these patients is a matter of concern for both the patients and their families and to attending physicians. Reported effects of tamoxifen on benign breast disease in premenopausal non high risk patients are scarce. Moreover published data has not yet revealed association of estrogen receptors in different benign breast lesions.The variability of response and its relation with estrogen receptor status is still a field of active investigation.

Conditions: Benign Breast Disease, Fibrocystic Disease of Breast, Fibroadenoma, Mastalgia
Being tested: Tamoxifen, Evening Primrose Oil
Keywords: Fibrocystic Breast Disease, Fibroadenoma, Mastalgia
Medical subject headings: Cystic Fibrosis, Fibrocystic Breast Disease, Fibroadenoma, Mastodynia

What participants receive

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

TamoxifenDrug
Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
Evening Primrose OilDrug
Evening Primrose Oil is given at 1000 mg two times daily for 3 months.

Study groups in NCT00999921
Study group	Role	What they receive
Tamoxifen	Experimental	10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months Receives: Drug: Tamoxifen
Evening Primrose Oil	Experimental	1000 mg daily for 3 months Receives: Drug: Evening Primrose Oil

What is being measured

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

Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)
Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.
Measured: 3 months
Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).
All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response
Measured: 3 months

Secondary outcomes (1)

Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)
All patients who had an increase in breast pain in the "perimenstrual period" were designated as having cyclical mastalgia. Response was assessed following treatment in terms of either persistence of cyclical mastalgia after 3 months of treatment or disappearance of cyclical mastalgia
Measured: 3 months

Timeline

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

Jan 2008Jan 2015

First posted22 Oct 2009 (estimated)
Study startJan 2008
Primary completionAug 2014
Study completionJan 2015

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Benign Breast DiseaseStudies of the same condition, open and under way.
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: Single blind
Who is masked: Participant
Enrolment: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00999921
Sponsor's protocol ID: MSVP-107/08
Status last verified: Apr 2015
First submitted: 21 Oct 2009
Last updated: 18 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Srivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence-based management of Mastalgia: a meta-analysis of randomised trials. Breast. 2007 Oct;16(5):503-12. doi: 10.1016/j.breast.2007.03.003. Epub 2007 May 16.
PubMed 17509880
Allegra JC, Lippman ME, Green L, Barlock A, Simon R, Thompson EB, Huff KK, Griffin W. Estrogen receptor values in patients with benign breast disease. Cancer. 1979 Jul;44(1):228-31. doi: 10.1002/1097-0142(197907)44:13.0.co;2-0.
PubMed 455247
Hurst JL, Mega JF, Hogg JP. Tamoxifen-induced regression of breast cysts. Clin Imaging. 1998 Mar-Apr;22(2):95-8. doi: 10.1016/s0899-7071(97)00076-4.
PubMed 9543585
Tan-Chiu E, Wang J, Costantino JP, Paik S, Butch C, Wickerham DL, Fisher B, Wolmark N. Effects of tamoxifen on benign breast disease in women at high risk for breast cancer. J Natl Cancer Inst. 2003 Feb 19;95(4):302-7. doi: 10.1093/jnci/95.4.302.
PubMed 12591986

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?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Blinded Randomized Controlled Trial of the Comparative Effects of Tamoxifen and Evening Primrose Oil in Premenopausal Non-high Risk Patients With Benign Breast Disease With Respect to the Estrogen Receptor Status.
ClinicalTrials.gov ID: NCT00999921
Acronym / sponsor ID: MSVP-107/08
Conditions: Benign Breast Disease, Fibrocystic Disease of Breast, Fibroadenoma, Mastalgia
Keywords: Fibrocystic Breast Disease, Fibroadenoma, Mastalgia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: Medical College and Hospital KolkataUniversity, hospital or other
Study start: Jan 2008
Primary completion: Aug 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 22 Oct 2009 (estimated)
Results: Posted 29 Apr 2015

Clinical summary

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

To do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Tamoxifen	Experimental	Drug: Tamoxifen10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
Evening Primrose Oil	Experimental	Drug: Evening Primrose Oil1000 mg daily for 3 months

Who may qualify

Ages: 16 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.
Benign Breast disease amenable to hormonal therapy.

Key exclusion criteria (8 listed)

Postmenopausal women.
Premenopausal women with pregnancy or other contraindications to tamoxifen.
Girls less than 16 years.
Very large lesions which require surgery for cosmesis.
High risk breast lesions like epitheliosis, atypia or atypical hyperplasia on histopathology or susceptible lesions prone to develop malignancy.

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
TamoxifenTamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.	Drug	Tamoxifen
Evening Primrose OilEvening Primrose Oil is given at 1000 mg two times daily for 3 months.	Drug	Evening Primrose Oil

Primary outcome

Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)
Time frame: 3 months
Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.
Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).
Time frame: 3 months
All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response

1 secondary outcome

Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)
Time frame: 3 months

Results and safety

Results posted to the registry on 29 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tamoxifen	127	117
Evening Primrose Oil	129	110

Primary outcome: Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)

Time frame: 3 months. Number. Unit: participants

Measure	Tamoxifen n = 102	Evening Primrose Oil n = 99
Fibroadenosis (total number)	63	61
Fibroadenosis (60% or more reduction in size)	54	14
Fibroadenosis (less than 60% reduction in size)	9	47
Fibroadenoma (total number)	39	38
Fibroadenoma (60% or more reduction in size)	4	0
Fibroadenoma (less than 60% reduction in size)	35	38

Population analysed: 102(out of 127) patients receiving Tamoxifen and 99(out of 129) receiving Evening Primrose Oil were assessed for reduction in lump size. The remaining patients had mastalgia with no lump, hence were excluded from this assessment. A 60% or more reduction in lump size after completion of the therapy was considered as a satisfactory response.

Primary outcome: Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).

Time frame: 3 months. Number. Unit: participants

Measure	Tamoxifen n = 88	Evening Primrose Oil n = 47
CBS I (excellent response)	71	10
CBS II (substantial response)	13	15
CBS III (poor response)	3	11
CBS IV (no response)	1	11

Population analysed: 88 patients treated with Tamoxifen and 47 patients treated with Evening Primrose Oil were assessed for Cardiff Breast Pain Score. Patients with fibroadenomas and those with Grade 0 pain at the beginning of therapy were excluded from this analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were assessed at 3 months after completion of therapy, after a 3 month followup and at 6 month followup. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tamoxifen	0 of 127 (0%)	82 of 127 (64.6%)	Not reported
Evening Primrose Oil	0 of 129 (0%)	0 of 129 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17509880Srivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence-based management of Mastalgia: a meta-analysis of randomised trials. Breast. 2007 Oct;16(5):503-12. doi: 10.1016/j.breast.2007.03.003. Epub 2007 May 16.
Background: PubMed 455247Allegra JC, Lippman ME, Green L, Barlock A, Simon R, Thompson EB, Huff KK, Griffin W. Estrogen receptor values in patients with benign breast disease. Cancer. 1979 Jul;44(1):228-31. doi: 10.1002/1097-0142(197907)44:13.0.co;2-0.
Background: PubMed 9543585Hurst JL, Mega JF, Hogg JP. Tamoxifen-induced regression of breast cysts. Clin Imaging. 1998 Mar-Apr;22(2):95-8. doi: 10.1016/s0899-7071(97)00076-4.
Background: PubMed 12591986Tan-Chiu E, Wang J, Costantino JP, Paik S, Butch C, Wickerham DL, Fisher B, Wolmark N. Effects of tamoxifen on benign breast disease in women at high risk for breast cancer. J Natl Cancer Inst. 2003 Feb 19;95(4):302-7. doi: 10.1093/jnci/95.4.302.

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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.

Md Tanveer Adil principal investigator

Resident, Department of Surgery, Medical College and Hospital, Kolkata

Rumana Rahman study director

Resident, Department of Gynaecology and Obstetrics, Medical College and Hospital, Kolkata

Soumen Das study director

Resident, Department of Surgery, Medical College and Hospital, Kolkata

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tamoxifen and Evening Primrose Oil in people with Benign Breast Disease and Fibrocystic Disease of Breast, run by Medical College and Hospital Kolkata at 1 site 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 2 inclusion and 8 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 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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 29 Apr 2015). 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 Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) (time frame: 3 months). The study lists 2 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 NCT00999921, which also lists 4 linked publications.

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 18 May 2015.