High Risk for Invasive Breast CancerPhase 2NCT07806630
SHORTened Duration of TAMoxifen
A Phase 2 study testing Tamoxifen and Tamoxifen (Nolvadex) in people with High Risk for Invasive Breast Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to learn whether a shorter-duration, low-dose tamoxifen regimen can reduce the risk of developing breast cancer or breast cancer recurrence in post-menopausal women who are at increased risk for breast cancer. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- High Risk for Invasive Breast Cancer
- What is being tested?
- Tamoxifen and Tamoxifen (Nolvadex)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patient at high risk for invasive breast cancer (either A or B)
- Post-menopausal women diagnosed with ductal carcinoma in situ (DCIS), Lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH), and atypical lobular hyperplasia (ALH) who meet the following criteria:
- DCIS/LCIS
- Lesion size ≤3cm
- Low or intermediate grade
- Lesion completely excised by surgical excision
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- Margins >2cm for DCIS
- Estrogen receptor (ER) positive and/or Progesterone receptor positive (defined as ≥10%)
- ADH/ALH o Lesion completely excised by surgical excision
- Patients at increased risk of breast cancer based on Gail model criteria (5- year risk ≥1.66%) without prior history of DCIS, LCIS, atypical hyperplasia, or invasive breast cancer.
- 2. No history of pathogenic germline mutations that increase the lifetime risk of breast cancer. If genetic testing was not done, then patients must have no more than two first-degree relatives diagnosed with breast cancer.
- 3. Should have received adjuvant radiation for DCIS, if recommended by the radiation oncologist.
- 4. No prior history of invasive carcinoma, DCIS, LCIS, ADH, and/or ALH in bilateral breasts.
- 5. ECOG performance status ≤ 2 6. No use of hormone replacement therapy for at least 5 years.
Who cannot join
- Evidence of invasive or microinvasive breast cancer.
- Current use of dicumarols and CYP2D6 inhibitors, such as selective serotonin reuptake inhibitors.
- Patients who have had a bilateral mastectomy for risk reduction.
- Prior history of any malignancy in the last 5 years (except squamous cell carcinoma/basal cell carcinoma of skin)
- Patients who are known to be pregnant
- Patients who cannot voluntarily provide informed consent. Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent.
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- Life expectancy of less than 1 year per treating physician.
- Prior treatment with tamoxifen or an aromatase inhibitor.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
About this study
Official title: SHORTened Duration of TAMoxifen for Risk Reduction in Breast Intraepithelial Neoplasms in Post-menopausal Women
The purpose of this study is to learn whether a shorter-duration, low-dose tamoxifen regimen can reduce the risk of developing breast cancer or breast cancer recurrence in post-menopausal women who are at increased risk for breast cancer.
Read the detailed description
The patients to be entered in this protocol will be post-menopausal women diagnosed with ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), atypical ductal hyperplasia, and atypical lobular hyperplasia (ALH) OR post-menopausal women with an elevated 5-year Gail model risk (> 1.66%) but with no prior history of breast intraepithelial or invasive cancers
Potential subjects will be recruited by the treating investigator and approached to participate in the study during consultation for the treatment and management of their disease as an alternative treatment option.
Subjects from all racial/ethnic groups are eligible for this study if they meet the eligibility criteria
- Conditions
- High Risk for Invasive Breast Cancer
- Being tested
- Tamoxifen, Tamoxifen (Nolvadex)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Low-dose tamoxifen will be administered at 10 mg orally every other day for 18 months.
Tamoxifen (Nolvadex)Drug
Low dose Tamoxifen for 18 months.
| Study group | Role | What they receive |
|---|---|---|
| Low dose Tamoxifen | Experimental | Not described Receives: Drug: Tamoxifen; Drug: Tamoxifen (Nolvadex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Dose Tamoxifen
To evaluate the efficacy of a de-escalated, 18-month regimen of low-dose tamoxifen (10 mg every other day) in reducing the risk of disease recurrence or invasive breast cancer in post-menopausal women with breast intraepithelial neoplasia or an elevated 5-year Gail model risk.
Measured: 18 Months
Secondary outcomes (2)
Evaluation of Tamoxifen Tolerability
Incidence of endometrial cancer or thromembolic events.
Measured: 18 months
To evaluate the Incidence of other invasive events
Incidence of LCIS or atypical hyperplasia in ipsilateral or contralateral breast.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Sep 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk for Invasive Breast CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The primary objective of this trial is to evaluate the efficacy of a shortened, low-dose chemoprevention regimen (tamoxifen 10 mg every other day for 18 months) in reducing the risk of developing invasive breast cancer or ipsilateral/contralateral breast recurrence in patients diagnosed with breast intraepithelial neoplasia (DCIS, ADH, ALH, LCIS) or those with an elevated 5-year Gail model risk (\> 1.66%). This objective aims to determine whether further shortening the duration of low-dose therapy can maintain the meaningful risk reduction observed in prior trials (such as TAM-01) while minimizing treatment burden and toxicities.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mridula George, MD, Rutgers, The State University of New Jersey
- Investigators
- Mridula George, MD, Principal investigator, Rutgers Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806630
- Sponsor's protocol ID
- 042606
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHORTened Duration of TAMoxifen for Risk Reduction in Breast Intraepithelial Neoplasms in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT07806630
- Acronym / sponsor ID
- 042606
- Conditions
- High Risk for Invasive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 8 Sep 2026 (actual)
- 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.
The purpose of this study is to learn whether a shorter-duration, low-dose tamoxifen regimen can reduce the risk of developing breast cancer or breast cancer recurrence in post-menopausal women who are at increased risk for breast cancer.
Detailed description
The patients to be entered in this protocol will be post-menopausal women diagnosed with ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), atypical ductal hyperplasia, and atypical lobular hyperplasia (ALH) OR post-menopausal women with an elevated 5-year Gail model risk (> 1.66%) but with no prior history of breast intraepithelial or invasive cancers
Potential subjects will be recruited by the treating investigator and approached to participate in the study during consultation for the treatment and management of their disease as an alternative treatment option.
Subjects from all racial/ethnic groups are eligible for this study if they meet the eligibility criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The primary objective of this trial is to evaluate the efficacy of a shortened, low-dose chemoprevention regimen (tamoxifen 10 mg every other day for 18 months) in reducing the risk of developing invasive breast cancer or ipsilateral/contralateral breast recurrence in patients diagnosed with breast intraepithelial neoplasia (DCIS, ADH, ALH, LCIS) or those with an elevated 5-year Gail model risk (> 1.66%). This objective aims to determine whether further shortening the duration of low-dose therapy can maintain the meaningful risk reduction observed in prior trials (such as TAM-01) while minimizing treatment burden and toxicities.
| Arm | Type | Receives |
|---|---|---|
| Low dose Tamoxifen | Experimental | Drug: Tamoxifen, Drug: Tamoxifen (Nolvadex) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Patient at high risk for invasive breast cancer (either A or B)
- Post-menopausal women diagnosed with ductal carcinoma in situ (DCIS), Lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH), and atypical lobular hyperplasia (ALH) who meet the following criteria:
- DCIS/LCIS
- ADH/ALH o Lesion completely excised by surgical excision
- Patients at increased risk of breast cancer based on Gail model criteria (5- year risk ≥1.66%) without prior history of DCIS, LCIS, atypical hyperplasia, or invasive breast cancer.
Key exclusion criteria (9 listed)
- Evidence of invasive or microinvasive breast cancer.
- Current use of dicumarols and CYP2D6 inhibitors, such as selective serotonin reuptake inhibitors.
- Patients who have had a bilateral mastectomy for risk reduction.
- Prior history of any malignancy in the last 5 years (except squamous cell carcinoma/basal cell carcinoma of skin)
- Patients who are known to be pregnant
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 |
|---|---|---|
| TamoxifenLow-dose tamoxifen will be administered at 10 mg orally every other day for 18 months. | Drug | Low dose Tamoxifen |
| Tamoxifen (Nolvadex)Low dose Tamoxifen for 18 months. | Drug | Low dose Tamoxifen |
Primary outcome
Low Dose Tamoxifen
Time frame: 18 Months
To evaluate the efficacy of a de-escalated, 18-month regimen of low-dose tamoxifen (10 mg every other day) in reducing the risk of disease recurrence or invasive breast cancer in post-menopausal women with breast intraepithelial neoplasia or an elevated 5-year Gail model risk.
2 secondary outcomes
Evaluation of Tamoxifen Tolerability
Time frame: 18 months
To evaluate the Incidence of other invasive events
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Mridula George, MD principal investigator
Rutgers Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen and Tamoxifen (Nolvadex) in people with High Risk for Invasive Breast Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
Low Dose Tamoxifen (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.