Breast CancerPhase 1NCT00001378
A Pilot Trial of Tamoxifen and 4-HPR (4-N-Hydroxyphenyl Retinamide) in Persons at High Risk for Developing Breast Cancer
A Phase 1 study testing fenretinide in people with Breast Cancer and Breast Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This is a pilot, chemoprevention study. Patients receive fenretinide daily for 25 of every 28 days for 4 months and tamoxifen daily for 23 months, beginning the second month of fenretinide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- fenretinide
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1994to Nov 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
POPULATION CHARACTERISTICS:
Women and men at increased risk for the development of breast cancer by at least one of the following criteria:
Histologically documented ductal carcinoma in situ (DCIS), including DCIS with minimal invasion or microinvasion.
Histologically documented lobular neoplasia, including lobular hyperplasia and lobular carcinoma in situ (LCIS).
Histologically documented atypical ductal hyperplasia in postmenopausal women.
Histologically documented atypical ductal hyperplasia in premenopausal women with 1 first-degree relative (mother or sister) diagnosed with breast cancer.
Histologically documented atypical ductal hyperplasia in premenopausal women with 3 or more relatives diagnosed with breast cancer provided at least 1 is a second-degree relative.
3 or more first- or second-degree relatives diagnosed with breast or ovarian cancer with at least 1 diagnosed with breast cancer.
2 or more premenopausal (under age 50) first-degree relatives diagnosed with breast cancer.
1 or more first-degree relatives diagnosed with breast cancer if at least 1 relative in the extended pedigree had ovarian cancer.
3 or more relatives with breast cancer with at least 1 first-degree relative diagnosed with premenopausal breast cancer.
Previously diagnosed Stage I breast cancer with surgery and/or radiotherapy only (without prior adjuvant chemo- or hormonal therapy).
Positive for the BRCA1/BRCA2 gene.
No history of other invasive breast cancer.
No evidence of malignancy on breast and gynecologic exams.
Participants with a family history of breast cancer will be seen in consultation by the Family Studies Branch, NCI.
PRIOR/CONCURRENT THERAPY:
Mastectomy or lumpectomy plus radiotherapy required prior to entry for patients with DCIS. Patients with DCIS who have participated in protocol NCI-MB-348 eligible.
No participation in any other breast cancer prevention study involving pharmacologic intervention.
No prior chemotherapy or hormonal therapy for invasive breast cancer.
At least 3 months since estrogen or progesterone replacement therapy or hormonal contraceptives.
PATIENT CHARACTERISTICS:
Age: 35 and over.
Performance status: Ambulatory.
Life expectancy: At least 10 years.
Hematopoietic: Complete blood count normal.
Hepatic:
Bilirubin normal.
Alkaline phosphate normal.
AST normal.
PT, PTT normal.
No history of bleeding disorder.
No history of chronic hepatitis or cirrhosis.
Renal:Creatinine less than 1.5 mg/dL.
Cardiovascular:
No history of deep venous thrombosis.
No history of pulmonary embolus.
Other:
No allergy to any study medication.
Capable of tolerating multiple diagnostic procedures.
No history of abnormal vaginal bleeding. Hysterectomy for vaginal bleeding of benign etiology allowed.
No history of retinal disease, macular degeneration, or night blindness.
No medical or psychiatric risk due to nonmalignant systemic disease that would preclude study participation.
No history of malignancy except: Curatively treated nonmelanomatous skin cancer. Curatively treated in situ cervical carcinoma. Hodgkin's disease treated more than 5 years ago.
No pregnant women.
Adequate contraception required of fertile patients during and for 12 months after fenretinide and for 2 months after tamoxifen.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
This is a pilot, chemoprevention study. Patients receive fenretinide daily for 25 of every 28 days for 4 months and tamoxifen daily for 23 months, beginning the second month of fenretinide.
Patients are removed from study for unacceptable toxicity, the development of invasive breast cancer, or for dysfunctional uterine bleeding.
Read the detailed description
This is a pilot chemo-prevention study of the combination tamoxifen and 4-HPR in persons at increased risk of developing invasive breast cancer. The objectives of the study are to determine the acute and cumulative toxicity of tamoxifen and 4-HPR in high risk persons; to assess the feasibility of obtaining adequate tissue to study potential intermediate biomarkers of proliferative disease and malignancy using nipple aspiration, four quadrant fine needle aspirates, and breast core needle biopsies; and to study the effects of tamoxifen and 4-HPR on TGF-beta isoforms and the proliferative markers ki67 and PCNA pre- and post-therapy.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- fenretinide
- Keywords
- 4-Quadrant Fine Needle Aspiration, Biomarkers, Chemoprevention, Nipple Suction Aspirates, TGF Beta
- Medical subject headings
- Breast Neoplasms, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenretinideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJan 1994
- Study completionNov 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001378
- Sponsor's protocol ID
- 940056
- Other IDs
- 94-C-0056
- Status last verified
- Nov 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
London SJ, Connolly JL, Schnitt SJ, Colditz GA. A prospective study of benign breast disease and the risk of breast cancer. JAMA. 1992 Feb 19;267(7):941-4.
PubMed 1734106Dupont WD, Page DL. Risk factors for breast cancer in women with proliferative breast disease. N Engl J Med. 1985 Jan 17;312(3):146-51. doi: 10.1056/NEJM198501173120303.
PubMed 3965932
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Tamoxifen and 4-HPR (4-N-Hydroxyphenyl Retinamide) in Persons at High Risk for Developing Breast Cancer
- ClinicalTrials.gov ID
- NCT00001378
- Acronym / sponsor ID
- 940056
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- 4-Quadrant Fine Needle Aspiration, Biomarkers, Chemoprevention, Nipple Suction Aspirates, TGF Beta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 1994
- Study completion
- Nov 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot, chemoprevention study. Patients receive fenretinide daily for 25 of every 28 days for 4 months and tamoxifen daily for 23 months, beginning the second month of fenretinide.
Patients are removed from study for unacceptable toxicity, the development of invasive breast cancer, or for dysfunctional uterine bleeding.
Detailed description
This is a pilot chemo-prevention study of the combination tamoxifen and 4-HPR in persons at increased risk of developing invasive breast cancer. The objectives of the study are to determine the acute and cumulative toxicity of tamoxifen and 4-HPR in high risk persons; to assess the feasibility of obtaining adequate tissue to study potential intermediate biomarkers of proliferative disease and malignancy using nipple aspiration, four quadrant fine needle aspirates, and breast core needle biopsies; and to study the effects of tamoxifen and 4-HPR on TGF-beta isoforms and the proliferative markers ki67 and PCNA pre- and post-therapy.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fenretinide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 1734106London SJ, Connolly JL, Schnitt SJ, Colditz GA. A prospective study of benign breast disease and the risk of breast cancer. JAMA. 1992 Feb 19;267(7):941-4.
- Background: PubMed 3965932Dupont WD, Page DL. Risk factors for breast cancer in women with proliferative breast disease. N Engl J Med. 1985 Jan 17;312(3):146-51. doi: 10.1056/NEJM198501173120303.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fenretinide in people with Breast Cancer and Breast Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001378, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.