For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer
Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see
CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women).
Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women years of 0.17 for tamoxifen vs. 0.0 for placebo) *. For stroke, the incidence rate per 1,000 women years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women years was 0.75 for tamoxifen versus 0.25 for placebo **.
Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.
* Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See
WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.
** See Table 3 under
CLINICAL PHARMACOLOGY, Clinical Studies.
SOLTAMOX solution, a nonsteroidal antiestrogen, is for oral administration. Each 5 mL solution contains 15.2 mg tamoxifen citrate, equivalent to 10 mg tamoxifen.
Tamoxifen citrate is indicated for the following:
Metastatic Breast Cancer
Tamoxifen citrate is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate therapy.
Adjuvant Treatment of Breast Cancer
Tamoxifen citrate is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.
Tamoxifen citrate is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation.
The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate therapy is likely to be beneficial.
Tamoxifen citrate reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate therapy for breast cancer.
Ductal Carcinoma in Situ (DCIS)
In women with DCIS, following breast surgery and radiation, tamoxifen citrate is indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy.
Current data from clinical trials support five years of adjuvant tamoxifen citrate therapy for patients with breast cancer.
Reduction in Breast Cancer Incidence in High Risk Women
Tamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label).
Tamoxifen citrate is indicated only for high-risk women. "High risk" is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model.
Media Articles Related to Soltamox (Tamoxifen)
Tamoxifen for breast cancer prevention of little benefit
Source: The Doctors Lounge - Oncology
Only women at very high risk for breast cancer experience a benefit according to a study published in the journal Cancer.
Published Studies Related to Soltamox (Tamoxifen)
A four week randomised control trial of adjunctive medroxyprogesterone and
tamoxifen in women with mania. 
Emerging research has suggested that hormone treatments such as selective
oestrogen receptor modulators (SERMs) or progestins may be useful in the
treatment of mania. The current pilot study compared the use of the SERM
tamoxifen and the progestin medroxyprogesterone acetate (MPA), as an adjunct to
mood stabiliser medications, for the treatment of mania symptoms in 51 women in a
28-day double blind, placebo controlled study...
National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and
Raloxifene trial: advancing the science of recruitment and breast cancer risk
assessment in minority communities. 
understanding of breast cancer risk assessment in minority communities... CONCLUSIONS: Recruitment strategies used in STAR for racial and ethnic minorities
Weight change associated with anastrozole and tamoxifen treatment in
postmenopausal women with or at high risk of developing breast cancer. 
Weight gain is commonly reported by breast cancer patients on tamoxifen or
aromatase inhibitors. Since weight gain may impact on outcome and compliance we
have prospectively assessed the effects of these agents on weight change in three
randomised trials for the treatment or prevention of breast cancer...
CYP2D6 and UGT2B7 genotype and risk of recurrence in tamoxifen-treated breast
cancer patients. 
for patient benefit from tamoxifen therapy... CONCLUSION: The results do not support the hypothesis that CYP2D6 genotype
Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for
premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. 
goserelin for early breast cancer in the neoadjuvant setting... INTERPRETATION: Given its favourable risk-benefit profile, the combination of
Clinical Trials Related to Soltamox (Tamoxifen)
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid [Active, not recruiting]
The primary objective is, first, the comparison of tamoxifen and anastrozole and, second,
the comparison of zoledronate added to standard adjuvant therapy with controls according to
disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer
treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard
adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal
blockade combined with an antiestrogen or aromatase inhibitor.
Tamoxifen in Patients With Oesophageal Cancer [Not yet recruiting]
Cancer of the gullet (oesophagus) is a lethal disease in which only 15% of patients survive
5 years once diagnosed. It is more common in men than women, and men appear to have a worse
prognosis. One suggestion for this gender difference is the sex hormone oestrogen, which
exerts its effect via oestrogen receptors. The role of oestrogen in breast cancer is well
described, and antioestrogen medication such as tamoxifen, which blocks oestrogen receptors
are in widespread and effective use. The role of oestrogen receptors in oesophageal cancer
however, is less well defined. Work conducted by the investigators, as well as another
research group in Australia showed that antioestrogens including tamoxifen, reduce
oesophageal cancer cell growth in the laboratory. To date, no studies have assessed the
effect of tamoxifen therapy on oesophageal cancer growth in humans. The investigators
propose a study to determine the effect of tamoxifen in patients with oesophageal cancer who
aren't undergoing surgery or chemotherapy. Patients will receive tamoxifen tablets daily for
4 weeks after which time a biopsy (sample of cancer tissue) will be taken at gastroscopy (a
flexible camera that is passed into the mouth through the gullet into the stomach). The
biopsy will be compared with the biopsy taken at the time of diagnosis to determine if
tamoxifen has had any effect on cancer cell growth. If this study shows that tamoxifen does
slow cancer cell growth it could lead to a larger study of patients with oesophageal cancer
taking tamoxifen for a longer time period to determine if there is any clinical benefit.
Tamoxifen Treatment in Patients With Motor Neuron Disease [Recruiting]
The aim of this study is to survey the effect of Tamoxifen in motor neuron disease (MND)
patients, amyotrophic lateral sclerosis (ALS) with regular riluzole usage. TDP-43 is
related to ALS. Increased the ubiquitinated or phosphorylated TDP-43 can cause animal model
of ALS, and TDP43 can be degraded either by proteasome or autophagy pathway system.
Autophagy pathway can be activated by mTOR inhibition, resulting in ameliorating TDP-43
accumulation and rescue in motor function in animal model. Tamoxifen had shown ability of
enhance both proteasome and autophagy pathway, therefore the investigators assume that
Tamoxifen probably can ameliorate TDP-43 accumulation and inclusion body formation in ALS.
Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS) [Completed]
The purpose of the study is to evaluate the safety and efficacy of high dose creatine and
two dosages of tamoxifen treatment in amyotrophic lateral sclerosis (ALS).
A Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors [Suspended]
Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of
the effect of systemic treatments. After relapse on first-line non-steroidal aromatase
inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant
(an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but
in this context of resistance, their efficacy are poor.
Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic
setting by a combination with therapy targeting signal transduction pathways. Other
transduction pathways seem to be involved in endocrine sensitivity/resistance, such as
LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of
p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated
protein kinase 2 (MAPKAP-K2).
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 2 ratings/reviews, Soltamox has an overall score of 7.50. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Soltamox review by 60 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || atypical hyperplasia in breast and hypothyrodism |
|Dosage & duration:|| || levothyroxine 50mcg tamoxifen ? (dosage frequency: once per day) for the period of life and 5 yers|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || The tamoxifen has kept my condition (benign) constant and with no signs of maligancy developing for ten years since the discovery of the condition. Levothyroxine raised my levels to normal and I am less fatigued and feeling generally healthy.|
|Side effects:|| || There were not side effects|
|Comments:|| || I took tamoxifen for 5 years on a daily basis and continue to have biannual checkups.
Levothyroxine stared with a 25mcg dosage. A follow up blood work showed the dosage had to be raised to 50 mcg and is what I am now taking.|
Soltamox review by 58 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || breast cancer|
|Dosage & duration:|| || 20 mg taken daily for the period of 4 years|
|Other conditions:|| || none|
|Other drugs taken:|| || none post chemotherapy|
|Benefits:|| || A non return of breast cancer|
|Side effects:|| || night sweats
polyps in the womb
brought about the menopause
|Comments:|| || I had a mastectomy and radio therapy followed by 6 months of chemotherapy and then tamoxifen. Weight gain and ceasing mensturation may have been caused byt he combined effects of the chemotherapyt and tamoxifen.
Given I had 3 polyps removed it was decided to cease tamoxifen in the 5th year.|
Page last updated: 2015-08-10