Soltamox

Sexual Precocity, Gynecomastia, Ovulation induction therapy + 12 more

Treatment

12 FDA approvals

20 Active Studies for Soltamox

What is Soltamox

Tamoxifen

The Generic name of this drug

Treatment Summary

Tamoxifen is a type of medication used to treat certain types of breast cancer and to prevent the development of breast cancer in high risk individuals. It is usually given alone or in combination with other treatments. Tamoxifen has generally been replaced by another drug called anastrozole, which has been found to have better survival rates, fewer side effects, and better patient compliance. Tamoxifen was approved by the FDA in 1977.

Nolvadex

is the brand name

image of different drug pills on a surface

Soltamox Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Nolvadex

Tamoxifen

1990

60

Approved as Treatment by the FDA

Tamoxifen, also called Nolvadex, is approved by the FDA for 12 uses which include Invasive Breast Cancer and Malignant Neoplasms .

Invasive Breast Cancer

Malignant Neoplasms

Estrogen Receptors

Breast Cancer

Ductal Carcinoma In Situ

Malignant Neoplasms

Breast Cancer

Breast

Breast Surgery

Carcinoma, Intraductal, Noninfiltrating

Breast Cancer Radiation

High Risk

Effectiveness

How Soltamox Affects Patients

Tamoxifen is a drug that can help stop the growth and spread of certain types of cancer. Its effects last for about two weeks, so it needs to be taken regularly for it to be effective. Taking too much of it can lead to breathing difficulties or seizures, so it is important to take the correct dose. It can also increase the risk of developing cancer of the uterus.

How Soltamox works in the body

Tamoxifen blocks the effects of estrogen on cells, which helps stop the growth of tumors. It does this by decreasing tumor growth factors, increasing a hormone that binds to estrogen, and causing apoptosis (cell death) in estrogen-sensitive cells. This cell death is thought to be caused by an increase in calcium ion levels or the introduction of a tumor growth factor.

When to interrupt dosage

The suggested dose of Soltamox relies upon the diagnosed condition, including Ovulation induction therapy, Malignant Neoplasms and McCune Albright Syndrome. The amount of dosage is contingent upon the method of delivery featured in the table below.

Condition

Dosage

Administration

Ovulation induction therapy

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Breast Surgery

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

High Risk

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Fibromatosis, Aggressive

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Estrogen Receptors

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Breast Cancer Radiation

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Breast

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Sexual Precocity

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Breast Cancer

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Carcinoma, Intraductal, Noninfiltrating

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Gynecomastia

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Ovarian Cancer

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Fibrous Dysplasia, Polyostotic

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Malignant Neoplasms

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Malignant Neoplasms

, 10.0 mg, 10.0 mg/mL, 20.0 mg, 2.0 mg/mL, 1.0 mg/mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Kit

Warnings

Soltamox has four contraindications, so its usage should be avoided when going through any of the conditions shown in the subsequent table.

Soltamox Contraindications

Condition

Risk Level

Notes

Venous Thrombosis

Do Not Combine

Pulse Frequency

Do Not Combine

Pulmonary Embolism

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Tamoxifen may interact with Pulse Frequency

There are 20 known major drug interactions with Soltamox.

Common Soltamox Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The serum concentration of Abemaciclib can be increased when it is combined with Tamoxifen.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Tamoxifen.

Alectinib

Major

The metabolism of Alectinib can be increased when combined with Tamoxifen.

Aminophylline

Major

The metabolism of Aminophylline can be increased when combined with Tamoxifen.

Anastrozole

Major

The serum concentration of Anastrozole can be decreased when it is combined with Tamoxifen.

Soltamox Toxicity & Overdose Risk

Taking too much tamoxifen can cause difficulty breathing and seizures in animals, and dizziness, tremors, and difficulty with coordination in humans. If someone overdoses on tamoxifen, supportive care should be provided as there is no specific treatment for an overdose.

image of a doctor in a lab doing drug, clinical research

Soltamox Novel Uses: Which Conditions Have a Clinical Trial Featuring Soltamox?

Presently, there are 930 active trials examining the potential of Soltamox to mitigate Breast Cancer Radiation, Gynecomastia and Malignant Neoplasms.

Condition

Clinical Trials

Trial Phases

Breast Cancer Radiation

1 Actively Recruiting

Phase 2

Malignant Neoplasms

0 Actively Recruiting

Fibrous Dysplasia, Polyostotic

1 Actively Recruiting

Phase 2

Breast Cancer

21 Actively Recruiting

Phase 2, Phase 1, Not Applicable

Ovulation induction therapy

0 Actively Recruiting

Breast Surgery

0 Actively Recruiting

Estrogen Receptors

0 Actively Recruiting

Malignant Neoplasms

5 Actively Recruiting

Phase 2, Not Applicable

Breast

0 Actively Recruiting

Carcinoma, Intraductal, Noninfiltrating

0 Actively Recruiting

Sexual Precocity

0 Actively Recruiting

Gynecomastia

0 Actively Recruiting

Fibromatosis, Aggressive

2 Actively Recruiting

Phase 2, Phase 3

Ovarian Cancer

13 Actively Recruiting

Phase 1, Phase 2, Not Applicable, Phase 3

High Risk

0 Actively Recruiting

Soltamox Reviews: What are patients saying about Soltamox?

5

Patient Review

2/14/2013

Soltamox for Breast Cancer

4.7

Patient Review

9/15/2012

Soltamox for Breast Cancer

Patient Q&A Section about soltamox

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is SOLTAMOX used for?

"SOLTAMOX can be used to treat adults with estrogen receptor-positive breast cancer that has spread to other parts of the body or early stage breast cancer after surgery and radiation."

Answered by AI

Who makes SOLTAMOX?

"Savient's wholly-owned subsidiary Rosemont Pharmaceuticals Ltd. located in Leeds, U.K. has created Soltamox. This is the first oral liquid product entry into the market from Savient's wholly-owned U.K. subsidiary. The product is an oral solution of tamoxifen, which will be available in the United States."

Answered by AI

How do you take SOLTAMOX?

"Doses of SOLTAMOX greater than 20 mg per day should be given in divided doses (morning and evening), as greater doses yield no additional clinical benefit in the adjuvant setting for breast cancer."

Answered by AI

How much does SOLTAMOX cost?

"The price of Soltamox is around $1,354.63, cheaper than the average retail price of $1,552.16 by 12%."

Answered by AI

Clinical Trials for Soltamox

Image of Human Performance Clinical Research Lab in Fort Collins, United States.

Virtual Exercise for Cancer

18+
All Sexes
Fort Collins, CO

The goal of this research study is to look at how live, online group exercise compares to recorded videos for helping increase physical activity levels, improve physical fitness and quality of life, and reduce loneliness among those living with and beyond cancer. The following aims have been established for this study: * Aim 1: Examine the effect of a group-based videoconference physical activity (PA) intervention on moderate to vigorous physical activity \[MVPA\] (i.e., aerobic and resistance exercise). * Aim 2: Examine the effect of the intervention on additional health-related outcomes including physical fitness (i.e., aerobic endurance, muscular strength), and quality of life at both timepoints. * Aim 3: Explore potential mediators and moderators of intervention effects. We will examine mediators (e.g., self-efficacy, outcome expectations, group cohesion) and moderators (e.g., age, cancer stage, neighborhood walkability) of the intervention on MVPA. * Exploratory Aim: Determine whether a group-based videoconference PA intervention reduces loneliness among cancer survivors. Researchers will randomize participants into one of two guided exercise groups that are 12-weeks long in duration. Participants will be asked to complete online fitness assessments and surveys as well as wear a physical activity monitor device and watch a few times throughout the study. The whole study is 9-months long in duration with a 6-month free-living period where no study activities will take place.

Recruiting
Has No Placebo

Human Performance Clinical Research Lab

Heather J Leach, PhD

Image of Princess Margaret Cancer Centre in Toronto, Canada.

Trauma-Focused CALM for Ovarian Cancer

18+
Female
Toronto, Canada

The goal of this clinical trial is to investigate if CALM-TF (Trauma-Focused Managing Cancer and Living Meaningfully) is effective in treating traumatic stress symptoms in women with advanced ovarian cancer. It will also learn whether the efficacy differs at new diagnosis versus at recurrence. The main questions it aims to answer are: 1. What is the effectiveness of CALM-TF in reducing traumatic stress symptoms in patients with newly diagnosed or recurrent advanced ovarian cancer, as measured at 3 and 6 months? 2. What are the effects of CALM-TF on depression, quality of life, and patient-perceived benefit of the intervention compared to usual care alone? 3. What are patient perceptions of their care experiences as explored through qualitative interviews? Researchers will compare CALM-TF to usual standard of care (which includes regular conversations with medical teams and meetings with social workers) to see if CALM-TF works to treat traumatic stress. Participants will: * Receive 3-6 sessions of CALM-TF over 3-6 months (45-60 minutes each) via video call, telephone, or in-person based on preference, OR receive usual care only * Complete questionnaires at baseline, 3 months, and 6 months * Continue to receive their standard cancer care throughout the study * Some participants may be invited to participate in qualitative interviews at 6 months

Phase 3
Waitlist Available

Princess Margaret Cancer Centre

Gary Rodin, MD

Image of Washington University School of Medicine in St Louis, United States.

Supplemental Imaging for Breast Cancer

25 - 55
Female
St Louis, MO

Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers). The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.

Waitlist Available
Has No Placebo

Washington University School of Medicine

Tabassum Ahmad, M.D.

Image of BAMF Health in Grand Rapids, United States.

GEH300079 PET/CT for Colorectal Cancer

18+
All Sexes
Grand Rapids, MI

This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET/CT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis. The detection of PC in patients with primary PDAC will be explored in the Phase 2 part of the study. The study is comprised of 2 distinct parts: Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET/CT in the PC indication. Phase 2 includes 2 cohorts: Cohort A (participants with colorectal, ovarian and gastric primary cancer), and Cohort B (participants with primary PDAC), where analysis of Cohort B is descriptive only. Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.

Phase 2 & 3
Waitlist Available

BAMF Health

GE Healthcare

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Image of Univeristy of North Carolina at Chapel Hill in Chapel Hill, United States.

Educational Videos for Gynecologic Cancer

18+
Female
Chapel Hill, NC

This pilot study aims to estimate rates of genetic testing in patients with ovarian and endometrial cancer before and after the implementation of educational videos about genetic testing. Subjects will be asked to view one of three videos relevant to their cancer diagnosis and genetic testing, and have the option to complete a brief satisfaction survey. A chart review to evaluate rates of genetic testing ordered and referrals placed to Genetics before and after the implementation of the videos will be conducted. Up to 15-20% of ovarian cancer and 3-5% of endometrial cancer is due to inherited genetic mutation. Given this association, the National Comprehensive Cancer Network (NCCN) recommends genetic counseling and testing for all individuals with a diagnosis of ovarian cancer and endometrial cancer. Some challenges to obtaining genetic counseling and testing include missed identification and referral of eligible patients by providers, lack of provider knowledge, and busy clinic visits limiting time for informed consent and maintaining patient autonomy for genetic testing. Although heterogeneous, the literature supports multimedia use in cancer genetics. However, there is a paucity of data in the field of gynecologic oncology for the role of integrating a multimedia approach to genetic counseling.

Recruiting
Has No Placebo

Univeristy of North Carolina at Chapel Hill

Katherine Tucker, MD

Image of National Institutes of Health Clinical Center in Bethesda, United States.

Algorithm-Based Treatment Options for Advanced Breast Cancer

18 - 120
All Sexes
Bethesda, MD

Background: Breast cancer is the most common cancer in US women. There are different types of breast cancers; some are aggressive and difficult to treat. Researchers want to know if an algorithm (ENLIGHT) can help choose approved drugs that will treat these cancers more effectively. Objective: To test whether ENLIGHT can find better treatments for aggressive breast cancers. Eligibility: People aged 18 years and older with triple-negative or endocrine therapy resistant breast cancer; the cancer must have either failed to respond to treatment or come back after treatment. Design: Participants will be screened. A sample of tissue taken from the tumor will be tested using ENLIGHT as well as another method (TruSight Oncology 500). Participants will be assigned to 1 of 3 groups based on the algorithm search results: Group 1: No drug option was recommended. Participants will continue with their standard treatment with their local doctors. Group 2: A drug already approved for the participant's disease was recommended, but the participant has not yet received it. These results will be sent to the participant's local doctors. Participants may return to the NIH if their disease gets worse after using the suggested drugs. Group 3: A drug approved for other uses was recommended. Participants will be treated with the recommended drugs at the NIH; their care will be managed by an NIH doctor. They will continue to receive treatment as long as the drugs are helping them. They will have follow-up visits for 2 years after treatment ends. Participants who are not treated at the NIH will be contacted for a check on their health every 3 months for 2 years.

Recruiting
Has No Placebo

National Institutes of Health Clinical Center

Padma S Rajagopal, M.D.

Image of Washington University School of Medicine in Saint Louis, United States.

ChatGPT Education for Breast Reconstruction in Breast Cancer

18+
All Sexes
Saint Louis, MO

In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT-generated patient education regarding possible reconstruction options) or the control group (usual patient education). All patients will complete a survey following their in-person consultation to assess their experience and overall satisfaction with the consultation process. Additionally, participating surgeons will complete a separate survey to evaluate their consultation experience, satisfaction, and to assess the accuracy and clinical utility of the ChatGPT-generated patient education materials. The surveys are designed to gather information on patient characteristics, organizational health literacy according to Brega et al. Other survey questions have been designed to meet the outcomes of this study and have not been based on previously published surveys.

Recruiting
Has No Placebo

Washington University School of Medicine (+1 Sites)

Saif M Badran, M.D., Ph.D., FRCS

Image of University of Calgary in Calgary, Canada.

Exercise Programs for Cancer

18+
All Sexes
Calgary, Canada

EXCEL will provide online and, where feasible, in-person exercise programs to individuals living with and beyond cancer (ILWBC). Research has shown that targeted programs that include tailored exercise prescriptions are more successful in helping individuals with chronic disease to incorporate physical activity and exercise into their daily routines. While ILWBC are advised by healthcare professionals (HCPs) to engage in exercise, there is a lack of cancer-specific exercise programs and cancer-trained exercise specialists in Canada, outside of the research setting. Considering the negative impact cancer and its treatments have on fitness and physical activity levels, community-based efforts towards improving access, uptake and maintenance of exercise programming are needed. This study will evaluate the benefits of a community-based or online EXCEL exercise program for people living with and beyond cancer across Canada, using a streamlined intake process compared to the original EXCEL Study (HREBA.CC-20-0098, NCT04478851). This 8 to 12-week program (intervention) will be delivered in-person or over virtual platform. It includes twice weekly supervised exercise classes.

Recruiting
Has No Placebo

University of Calgary (+4 Sites)

Nicole Culos-Reed, PhD

Have you considered Soltamox clinical trials?

We made a collection of clinical trials featuring Soltamox, we think they might fit your search criteria.
Go to Trials

Have you considered Soltamox clinical trials?

We made a collection of clinical trials featuring Soltamox, we think they might fit your search criteria.
Go to Trials