Phase III, Randomized, Double Blind Trial Low Dose Tamoxifen Versus Placebo in Hormone Replacement Therapy (HRT) Users (HOT)
This study is ongoing, but not recruiting participants.
Sponsor:
European Institute of Oncology
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01579734
First received: January 24, 2012
Last updated: April 17, 2012
Last verified: December 2011
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Purpose
The propose of this trial is to assess the effect of low dose tamoxifen for breast cancer prevention in HRT (Hormone Replacement Therapy)users.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Tamoxifen Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | The HOT Study: Hormone Replacement Therapy Opposed by Low Dose Tamoxifen. A Phase III Trial of Breast Cancer Prevention With Low Dose Tamoxifen in HRT Users. |
Resource links provided by NLM:
Further study details as provided by European Institute of Oncology:
Primary Outcome Measures:
- breast cancer incidence [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]The primary objective is to assess if tamoxifen at a low dose reduces the incidence of breast cancer in healthy postmenopausal women undergoing or willing to initiate hormone replacement therapy (HRT), including the women who will eventually withdraw HRT during the 5 year intervention period and additional 5 years of follow up.
Secondary Outcome Measures:
- Incidence of adverse events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Incidence of: other non-invasive breast disorders (i.e., LCIS, atypical hyperplasia) All other cancers (with special reference to endometrial cancer, colorectal cancer, ovarian cancer and melanoma).
Bone fractures Cardiovascular events Venous thromboembolic events Clinically manifest cataract Overall mortality
| Enrollment: | 1884 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
1 tablet day for 5 years
|
Drug: Placebo
1 tablet day for 5 years
|
|
Active Comparator: Tamoxifen
Tamoxifen 5 mg, (1 tablet) day for 5 years
|
Drug: Tamoxifen
1 tablet, 5 mg / day for 5 years
Other Name: Nolvadex, Istubal, Valodex
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Postmenopausal women candidates to HRT for control of menopausal symptoms or prevention of postmenopausal disorders. women currently undergoing HRT for any duration; (women off HRT for 1 year or longer are considered de novo users);
- negative bilateral mammography (within the last 6 months);
- written informed consent.
Exclusion Criteria:
Any type of malignancy, with the exclusion of CIN and non-melanoma skin cancer;
- active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps, symptomatic myomata;
- alterations of metabolic, liver, renal and cardiac grade 2 function (NCI criteria grade 2 or higher);
- any type of retinal disorders, severe cataract and glaucoma;
- presence of significant risk factors for venous events, including immobilization within the last 3 months for longer than 2 weeks following surgery or trauma, history of estrogen-associated and "sine causa" superficial phlebitis, deep venous thrombophlebitis or other significant VTE (pulmonary embolism, stroke, etc.);
- use of tamoxifen, raloxifene or other SERMs within the last 4 weeks;
- anticoagulant therapy in progress (heparin or dicoumarol);
- active infections;
- severe psychiatric disorders or inability to comply to the protocol procedures; any other factor that at the investigator's discretion contraindicates the use of either tamoxifen or HRT.
Contacts and Locations More Information
No publications provided
| Responsible Party: | European Institute of Oncology |
| ClinicalTrials.gov Identifier: | NCT01579734 History of Changes |
| Other Study ID Numbers: | IEO S51/200 |
| Study First Received: | January 24, 2012 |
| Last Updated: | April 17, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by European Institute of Oncology:
|
breast cancer chemoprevention postmenopause |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013