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:
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01579734
First received: January 24, 2012
Last updated: June 17, 2014
Last verified: June 2014
  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 2015
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579734

Locations
Italy
European Institute of Oncology
Milan, Italy, 20141
Sponsors and Collaborators
European Institute of Oncology
Investigators
Study Chair: Umberto Veronesi, MD European Institute of Oncology
  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: June 17, 2014
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
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014