Breast CancerPhase 1NCT00001504
A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
A Phase 1 study testing 9-cis-Retinoic Acid in people with Breast Cancer and Breast Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Breast Neoplasm
- What is being tested?
- 9-cis-Retinoic Acid
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 1996to Jan 2002
- 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
DISEASE CHARACTERISTICS:
All patients must have histologically documented diagnosis of Stage III, or IV breast carcinoma.
Patients with stage III that has completed chemotherapy: Estrogen receptor (ER) or progesterone receptor (PR) positive tumor required if premenopausal. Either ER/PR-positive or -negative tumor allowed if postmenopausal and have received prior chemotherapy.
Patients may have stage IV with ER/PR-positive or -negative tumor.
No CNS metastases, pseudotumor cereri, or seizures.
PRIOR/CONCURRENT THERAPY:
Patients who have ecovered from the toxic effects of prior therapy will be eligible.
Patients with prior tamoxifen will be allowed to participate. At least 3 weeks must have elapsed since the last dose of chemotherapy.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Sex: Men and women.
Menopausal status: Any status.
Patients must have a performance status of ECOG 0-2.
Patients must have Hematopoietic criteria of:
ANC at least 1,500/mm(3).
Platelet count at least 90,000/mm(3).
Patients must have Hepatic criteria of:
In the absence of tumor involvement:
Bilirubin no greater than twice normal;
SGOT no greater than twice normal;
Alkaline phosphate no greater than twice normal;
Fasting triglycerides less than 3 times normal.
Patients must have Renal criteria of:
Serum creatinine no greater than 1.5 mg/dL OR;
Creatinine clearance at least 60 mL/min.
Other:
No allergy to study medications.
No nonmalignant systemic disease that would preclude therapy.
No second malignancy within 5 years except: Curatively treated basal cell skin carcinoma. Cervical carcinoma in situ.
Pregnant women will be excluded.
Negative pregnancy test required within 7 days prior to entry.
Adequate contraception required for 4 weeks prior to, during, and for 1 year after study.
Patients must give informed consent.
Patients who are poor medical or psychiatric risks will be eligible.
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 dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.
Read the detailed description
This is a Phase I study of the combination tamoxifen and 9-cis-Retinoic acid in patients with breast cancer. The primary objective of the study is; 1) to determine the maximum tolerated dose of 9-cis-Retinoic acid in combination with Tamoxifen and to determine the overall and dose limiting toxicities. Other objectives are: 2) to determine the effect of Tamoxifen on the pharmacokinetics of 9-cis-Retinoic acid; 3) to evaluate the anti-tumor activity of this combination therapy within the context of a phase I study; 4) and to determine the expression of surrogate biomarkers of breast carcinogenesis before and after treatment.
- Conditions
- Breast Cancer, Breast Neoplasm
- Being tested
- 9-cis-Retinoic Acid
- Keywords
- Retinoids, Biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-cis-Retinoic AcidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMay 1996
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 18 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001504
- Sponsor's protocol ID
- 960080
- Other IDs
- 96-C-0080
- Status last verified
- Jan 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Fontana JA. Interaction of retinoids and tamoxifen on the inhibition of human mammary carcinoma cell proliferation. Exp Cell Biol. 1987;55(3):136-44. doi: 10.1159/000163409.
PubMed 3666278Welsch CW, DeHoog JV. Retinoid feeding, hormone inhibition, and/or immune stimulation and the genesis of carcinogen-induced rat mammary carcinomas. Cancer Res. 1983 Feb;43(2):585-91.
PubMed 6401220Jordan VC, Murphy CS. Endocrine pharmacology of antiestrogens as antitumor agents. Endocr Rev. 1990 Nov;11(4):578-610. doi: 10.1210/edrv-11-4-578. No abstract available.
PubMed 2292243
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 Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00001504
- Acronym / sponsor ID
- 960080
- Conditions
- Breast Cancer, Breast Neoplasm
- Keywords
- Retinoids, Biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 1996
- Study completion
- Jan 2002
- First posted
- 4 Nov 1999 (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 dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.
Detailed description
This is a Phase I study of the combination tamoxifen and 9-cis-Retinoic acid in patients with breast cancer. The primary objective of the study is; 1) to determine the maximum tolerated dose of 9-cis-Retinoic acid in combination with Tamoxifen and to determine the overall and dose limiting toxicities. Other objectives are: 2) to determine the effect of Tamoxifen on the pharmacokinetics of 9-cis-Retinoic acid; 3) to evaluate the anti-tumor activity of this combination therapy within the context of a phase I study; 4) and to determine the expression of surrogate biomarkers of breast carcinogenesis before and after treatment.
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 |
|---|---|---|
| 9-cis-Retinoic Acid | 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 3666278Fontana JA. Interaction of retinoids and tamoxifen on the inhibition of human mammary carcinoma cell proliferation. Exp Cell Biol. 1987;55(3):136-44. doi: 10.1159/000163409.
- Background: PubMed 6401220Welsch CW, DeHoog JV. Retinoid feeding, hormone inhibition, and/or immune stimulation and the genesis of carcinogen-induced rat mammary carcinomas. Cancer Res. 1983 Feb;43(2):585-91.
- Background: PubMed 2292243Jordan VC, Murphy CS. Endocrine pharmacology of antiestrogens as antitumor agents. Endocr Rev. 1990 Nov;11(4):578-610. doi: 10.1210/edrv-11-4-578. No abstract available.
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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 9-cis-Retinoic Acid in people with Breast Cancer and Breast Neoplasm, 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 NCT00001504, which also lists 3 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.