Triple Negative Breast CancerPhase 2NCT05528133
Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer
A Phase 2 study testing Genomically Guided Radiation Therapy in people with Triple Negative Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Genomically Guided Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2023to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection
- Confirmation of Triple Negative (TN) breast cancer by tissue biopsy
- Adequate tissue to calculate RSI
- To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines
- To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor [ER] and progesterone receptor [PR]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
- Life expectancy >16 weeks
Show all 12Show fewer
- KPS ≥ 70
- Age ≥ 18 years
- Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
- There is no limit on prior systemic therapies
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
- Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment
Who cannot join
- Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation
- Women who are pregnant or breastfeeding
- Positive surgical margins
- History of allergy or hypersensitivity to any of the study drugs or study drug components
- Metastatic breast cancer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Morton Plant Hospital - Baycare Health System
Clearwater, Florida, 33756
Ken Tardif, 727-462-3921, Ken.Tardif@baycare.org
Ronica H. Nanda, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Kamran Ahmed, MD
Ronica H Nanda, MD
About this study
Official title: Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Genomically Guided Radiation Therapy
- Keywords
- Breast Cancer, Genomically Guided Radiation
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomically Guided Radiation TherapyRadiation
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity.
Genomically Guided Radiation TherapyRadiation
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity.
| Study group | Role | What they receive |
|---|---|---|
| Radiosensitivity Index optimized | Experimental | Participants will be assigned to optimized arm based on their RSI score. Participants will receive whole breast radiation therapy with or without regional lymph node irradiation as appropriate with or without a boost to the lumpectomy cavity. Receives: Radiation: Genomically Guided Radiation Therapy |
| Radiosensitivity Index not optimized | Active comparator | Participants will receive standard of care whole breast radiation therapy with or without regional lymph node irradiation as appropriate with a boost to the lumpectomy cavity. Receives: Radiation: Genomically Guided Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control
Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging
Measured: At 3 Years
Secondary outcomes (4)
Overall Survival (OS)
OS will be measured from the date of study initiation to the date of death due to any cause.
Measured: Up to 5 Years
Progression Free Survival (PFS)
PFS is measured from the date of first treatment to the date of first observation of PD or death due to any cause.
Measured: Up to 5 years
Distant Control
Distant control will be defined by lack of progression outside the irradiated treatment field
Measured: Up to 5 Years
Quality of Life following Genomically Guided Dose Personalization
Quality of life (QOL) will be assessed through the completion of the Functional Assessment of Cancer Therapy for Breast Cancer questionnaire (FACT-B). This quality of life questionnaire contains questions from the FACT-General (G) questionnaire in the domains of physical, social/family, emotional, and functional well-being as well as additional questions pertaining to patients with breast cancer. The questionnaire will be completed at screening, during protocol therapy and at follow-up visits
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start25 Jan 2023
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamran Ahmed, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528133
- Sponsor's protocol ID
- MCC-21757
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05528133
- Acronym / sponsor ID
- MCC-21757
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Breast Cancer, Genomically Guided Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 6 Sep 2022 (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 the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiosensitivity Index optimized | Experimental | Radiation: Genomically Guided Radiation TherapyParticipants will be assigned to optimized arm based on their RSI score. Participants will receive whole breast radiation therapy with or without regional lymph node irradiation as appropriate with or without a boost to the lumpectomy cavity. |
| Radiosensitivity Index not optimized | Active comparator | Radiation: Genomically Guided Radiation TherapyParticipants will receive standard of care whole breast radiation therapy with or without regional lymph node irradiation as appropriate with a boost to the lumpectomy cavity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection
- Confirmation of Triple Negative (TN) breast cancer by tissue biopsy
- Adequate tissue to calculate RSI
- To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines
- To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor [ER] and progesterone receptor [PR]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
Key exclusion criteria (5 listed)
- Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation
- Women who are pregnant or breastfeeding
- Positive surgical margins
- History of allergy or hypersensitivity to any of the study drugs or study drug components
- Metastatic breast cancer
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 |
|---|---|---|
| Genomically Guided Radiation TherapyParticipants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity. | Radiation | Radiosensitivity Index optimized |
| Genomically Guided Radiation TherapyParticipants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity. | Radiation | Radiosensitivity Index not optimized |
Primary outcome
Local Control
Time frame: At 3 Years
Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging
4 secondary outcomes
Overall Survival (OS)
Time frame: Up to 5 Years
Progression Free Survival (PFS)
Time frame: Up to 5 years
Distant Control
Time frame: Up to 5 Years
Quality of Life following Genomically Guided Dose Personalization
Time frame: Up to 5 Years
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 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kamran Ahmed, MD principal investigator
Moffitt Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genomically Guided Radiation Therapy in people with Triple Negative Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites 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 12 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 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 2 sites 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?
Contact Robin Dowell (813-745-0393, Robin.Dowell@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (time frame: At 3 Years). 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 25 Sep 2026.