Trial Outcomes & Findings for Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer (NCT NCT00999921)

Last Updated: 2015-05-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

256 participants

Primary outcome timeframe

3 months

Results posted on

2015-05-18

Participant Flow

Premenopausal women with Benign Breast Disease and who belong to non-high risk group for breast cancer were included in the study

Postmenopausal women, premenopausal women with pregnancy or other contraindications to tamoxifen, girls less than 15 years, very large lesions, high risk patients with epitheliosis, atypia or atypical hyperplasia or prone to develop malignancy and patients unwilling to undergo treatment were excluded from the study

Participant milestones

Participant milestones
Measure	Tamoxifen Tamoxifen 10 mg OD from 5th day to 25th day of menstrual cycle for 3 months	Evening Primrose Oil Evening Primrose Oil 1000 mg daily for 3 months
Overall Study STARTED	127	129
Overall Study COMPLETED	117	110
Overall Study NOT COMPLETED	10	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Tamoxifen Tamoxifen 10 mg OD from 5th day to 25th day of menstrual cycle for 3 months	Evening Primrose Oil Evening Primrose Oil 1000 mg daily for 3 months
Overall Study Lost to Follow-up	10	19

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tamoxifen n=127 Participants Tamoxifen was administered at a dose of 10 mg once daily ffrom 5th day to 25 th day of menstrual cycle for 3 months	Evening Primrose Oil n=129 Participants Evening Primrose Oil was administered at a dose of 1000 mg daily for 3 months	Total n=256 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	124 Participants n=5 Participants	127 Participants n=7 Participants	251 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25.38 years STANDARD_DEVIATION 4.2 • n=5 Participants	25.16 years STANDARD_DEVIATION 3.8 • n=7 Participants	25.27 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants	129 Participants n=7 Participants	256 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment India	127 participants n=5 Participants	129 participants n=7 Participants	256 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 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.

Outcome measures

Outcome measures
Measure	Tamoxifen n=102 Participants Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months	Evening Primrose Oil n=99 Participants Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) Fibroadenosis (total number)	63 participants	61 participants
Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) Fibroadenosis (60% or more reduction in size)	54 participants	14 participants
Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) Fibroadenosis (less than 60% reduction in size)	9 participants	47 participants
Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) Fibroadenoma (total number)	39 participants	38 participants
Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) Fibroadenoma (60% or more reduction in size)	4 participants	0 participants
Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) Fibroadenoma (less than 60% reduction in size)	35 participants	38 participants

PRIMARY outcome

Timeframe: 3 months

Population: 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.

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

Outcome measures

Outcome measures
Measure	Tamoxifen n=88 Participants Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months	Evening Primrose Oil n=47 Participants Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). CBS I (excellent response)	71 participants	10 participants
Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). CBS II (substantial response)	13 participants	15 participants
Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). CBS III (poor response)	3 participants	11 participants
Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). CBS IV (no response)	1 participants	11 participants

SECONDARY outcome

Timeframe: 3 months

Population: 114 patients were identified as having cyclical mastalgia of whom 58 patients(37 fibroadenosis, 3 fibroadenonomas and 18 mastalgias with no lump) received Tamoxifen and 56 (36 fibroadenosis, 3 fibroadenomas and 17 mastalgias with no lump) received Evening Primrose Oil for 3 months. Good response was defined as disappearance of cyclical 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

Outcome measures

Outcome measures
Measure	Tamoxifen n=58 Participants Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months	Evening Primrose Oil n=56 Participants Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) Fibroadenosis(total number)	37 participants	36 participants
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) Fibroadenosis (good response)	30 participants	11 participants
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) Fibroadenosis (poor response)	7 participants	25 participants
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) Fibroadenoma (total number)	3 participants	3 participants
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) Fibroadenoma (good response)	3 participants	1 participants
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) Fibroadenoma (poor response)	0 participants	2 participants
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) Mastalgia with no lump (total number)	18 participants	17 participants
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) Mastalgia with no lump (good response)	17 participants	3 participants
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) Mastalgia with no lump (poor response)	1 participants	14 participants

Adverse Events

Tamoxifen

Serious events: 0 serious events

Other events: 82 other events

Deaths: 0 deaths

Evening Primrose Oil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tamoxifen n=127 participants at risk Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months	Evening Primrose Oil n=129 participants at risk Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
Skin and subcutaneous tissue disorders Hot Flushes	46.5% 59/127 • Number of events 59 • Adverse Events were assessed at 3 months after completion of therapy, after a 3 month followup and at 6 month followup Major adverse effect = Menstrual Irregularity, Minor adverse effects = 1) Hot flushes 2) Nausea and vomiting 3) Mood changes Presence of major or minor adverse effect at any period of followup was considered as an adverse effect of the total number of participants in the respective arm of the study.	0.00% 0/129 • Adverse Events were assessed at 3 months after completion of therapy, after a 3 month followup and at 6 month followup Major adverse effect = Menstrual Irregularity, Minor adverse effects = 1) Hot flushes 2) Nausea and vomiting 3) Mood changes Presence of major or minor adverse effect at any period of followup was considered as an adverse effect of the total number of participants in the respective arm of the study.
Gastrointestinal disorders Nausea	15.0% 19/127 • Number of events 19 • Adverse Events were assessed at 3 months after completion of therapy, after a 3 month followup and at 6 month followup Major adverse effect = Menstrual Irregularity, Minor adverse effects = 1) Hot flushes 2) Nausea and vomiting 3) Mood changes Presence of major or minor adverse effect at any period of followup was considered as an adverse effect of the total number of participants in the respective arm of the study.	0.00% 0/129 • Adverse Events were assessed at 3 months after completion of therapy, after a 3 month followup and at 6 month followup Major adverse effect = Menstrual Irregularity, Minor adverse effects = 1) Hot flushes 2) Nausea and vomiting 3) Mood changes Presence of major or minor adverse effect at any period of followup was considered as an adverse effect of the total number of participants in the respective arm of the study.
Psychiatric disorders Mood Changes	3.1% 4/127 • Number of events 4 • Adverse Events were assessed at 3 months after completion of therapy, after a 3 month followup and at 6 month followup Major adverse effect = Menstrual Irregularity, Minor adverse effects = 1) Hot flushes 2) Nausea and vomiting 3) Mood changes Presence of major or minor adverse effect at any period of followup was considered as an adverse effect of the total number of participants in the respective arm of the study.	0.00% 0/129 • Adverse Events were assessed at 3 months after completion of therapy, after a 3 month followup and at 6 month followup Major adverse effect = Menstrual Irregularity, Minor adverse effects = 1) Hot flushes 2) Nausea and vomiting 3) Mood changes Presence of major or minor adverse effect at any period of followup was considered as an adverse effect of the total number of participants in the respective arm of the study.

Additional Information

Md Tanveer Adil

Medical College and Hospital Kolkata

Phone: 0091-9830154566

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place