Breast Tenderness and Cancer
by Leifson Ball, RPh
May 1, 2010
brought to you by Bellevue Pharmacy, a ProjectAWARE
“New-Onset Breast Tenderness During Hormone Therapy Linked to
Increased Breast Cancer Risk”, Arch Internal Med/ Vol. 169 Oct.
Purpose of the Study:
The purpose of the study was to evaluate the effects of conjugated equine
estrogens plus medroxyprogesterone on breast tenderness and how it may
be related to breast cancer.
The study was based on data from the Women’s Health Initiative
(WHI) (Estrogen plus Progestin) Trial which followed 16,608 postmenopausal
women between the ages of 50 and 79 years. The hypothesis was that breast
cancer seen in the WHI trial was associated with preceding breast tenderness.
Breast tenderness is considered a common adverse effect of conjugated
estrogen and medroxyprogesterone therapy.
Results from the study:
Breast cancer risk was significantly higher in women with new onset breast
tenderness as compared with those without the estrogen plus progestin
These results are based on a hypothesis derived from the criteria for
monitoring the patients in the WHI trial. One of the various monitoring
parameters was breast tenderness. The trial assessed breast tenderness
Limitations of the Study:
Lack of annual vs. more frequent assessments of breast tenderness.
High rates of discontinuation of therapy.
The WHI trial ended early.
The WHI trial did not address the long term benefits of HRT.
The WHI trial was limited to only conjugated equine estrogens and
medroxyprogesterone and does not apply to other hormone formulations.
Exclusion of younger menopausal women with significant menopausal
The flaws initially seen with the WHI trial may be extrapolated to this
study for the reason that the authors are using the same data to prove
This study appears to portray that women that demonstrate new breast
tenderness during conjugated estrogen/medroxyprogesterone therapy may
show an indication of breast cancer. If this is true, women using this
type of therapy would need to be concerned every time they exhibit any
type of breast tenderness.
Breast tenderness in general, is considered a common adverse effect of
conjugated estrogen and medroxyprogesterone therapy. This does not mean,
however, that the person has breast cancer. It is merely a possible indication
for breast cancer.
Also the study does not take into consideration the use of other hormone
formulations, including bioidentical therapy, which may provide a different
risk-benefit profile for breast tenderness and how it may be associated
with breast cancer. Breast tenderness that lasts more than a few days
should be followed up by a health care professional to determine basis
for the ongoing symptom.
For questions and further information, contact Bellevue