Breast CancerPhase 2CLARANCT07643428
Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors
A Phase 2 study testing Mini rTG OMEGA-3 Fish Oil in people with Breast Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a single-arm Phase 2 interventional treatment study to investigate changes in tissue lipidomes with omega-3 polyunsaturated fatty acids (PUFA) supplementation and correlations with pathological response in patients with early-stage breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mini rTG OMEGA-3 Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jun 2028
- 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
- Patient must be ≥18 years of age.
- Breast tumor ≥1 cm.
- Not currently taking dietary supplements containing fish oil or omega-3 PUFAs. A diet containing fish meat is permitted.
- Unilateral and/or bilateral diagnostic breast mammogram and/or ultrasound within 60 days of enrollment. If breast MRI is done per treating physician's discretion, at least one breast imaging modality should be within 60 days of enrollment.
- Pathologically proven diagnosis of invasive breast cancer, clinical stage I-III (cT1c-T4, N0-N3, M0).
- Concurrent (neoadjuvant) systemic anti-cancer therapy is planned, including but not limited to endocrine therapy, chemotherapy, anti-HER2 therapy, and immunotherapy.
Show all 12Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Bilateral breast cancer and/or multifocal, multicentric disease is allowed.
- Appropriate pretreatment evaluations for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup: history/physical examination, including breast exam (inspection and palpation of the breasts), within 30 days prior to study entry.
- Patients with a prior history of breast cancer will be considered eligible.
- Surgical candidacy as determined by the treating physician.
- Patient must provide study-specific informed consent prior to study entry or have a legally authorized representative provide consent.
Who cannot join
- American Joint Committee on Cancer (AJCC) clinical M1 breast cancer (i.e., with distant metastasis).
- Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
- Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol treatment or providing informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Lubna Chaudhary, MD, MS, 414-805-4600, lchaudhary@mcw.edu
About this study
Official title: Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors (CLARA)
This is a single-arm Phase 2 interventional treatment study to investigate changes in tissue lipidomes with omega-3 polyunsaturated fatty acids (PUFA) supplementation and correlations with pathological response in patients with early-stage breast cancer. Patients will be treated with a dietary supplement enriched with omega-3 PUFA (O3Supp) for 4 to 28 weeks prior to surgical resection of a breast tumor(s). Concurrent standard-of-care neoadjuvant treatment with clinically indicated systemic agents (such as chemotherapy, endocrine therapy, anti-HER2 therapy, immunotherapy) is allowed.
- Conditions
- Breast Cancer
- Being tested
- Mini rTG OMEGA-3 Fish Oil
- Keywords
- omega-3 Polyunsaturated fatty acids
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini rTG OMEGA-3 Fish OilDrug
Subjects will take six (6) soft gel capsules daily.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | Mini rTG OMEGA-3 fish oil is a commercially available dietary supplement in the form of soft gel capsules. Receives: Drug: Mini rTG OMEGA-3 Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid species in primary breast tumors
The number of subjects with increased levels of DHA-containing and EPA-containing lipid species in primary breast tumors.
Measured: Up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lubna Chaudhary, Medical College of Wisconsin
- Investigators
- Lubna Chaudhary, MD, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643428
- Sponsor's protocol ID
- PRO00059463
- Acronym
- CLARA
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2026
- Last updated
- 20 Oct 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors (CLARA)
- ClinicalTrials.gov ID
- NCT07643428
- Acronym / sponsor ID
- CLARA / PRO00059463
- Conditions
- Breast Cancer
- Keywords
- omega-3 Polyunsaturated fatty acids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 11 Jun 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.
This is a single-arm Phase 2 interventional treatment study to investigate changes in tissue lipidomes with omega-3 polyunsaturated fatty acids (PUFA) supplementation and correlations with pathological response in patients with early-stage breast cancer. Patients will be treated with a dietary supplement enriched with omega-3 PUFA (O3Supp) for 4 to 28 weeks prior to surgical resection of a breast tumor(s). Concurrent standard-of-care neoadjuvant treatment with clinically indicated systemic agents (such as chemotherapy, endocrine therapy, anti-HER2 therapy, immunotherapy) is allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention | Experimental | Drug: Mini rTG OMEGA-3 Fish OilMini rTG OMEGA-3 fish oil is a commercially available dietary supplement in the form of soft gel capsules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient must be ≥18 years of age.
- Breast tumor ≥1 cm.
- Not currently taking dietary supplements containing fish oil or omega-3 PUFAs. A diet containing fish meat is permitted.
- Unilateral and/or bilateral diagnostic breast mammogram and/or ultrasound within 60 days of enrollment. If breast MRI is done per treating physician's discretion, at least one breast imaging modality should be within 60 days of enrollment.
- Pathologically proven diagnosis of invasive breast cancer, clinical stage I-III (cT1c-T4, N0-N3, M0).
Key exclusion criteria (3 listed)
- American Joint Committee on Cancer (AJCC) clinical M1 breast cancer (i.e., with distant metastasis).
- Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
- Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol treatment or providing informed consent.
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 |
|---|---|---|
| Mini rTG OMEGA-3 Fish OilSubjects will take six (6) soft gel capsules daily. | Drug | Dietary Intervention |
Primary outcome
Lipid species in primary breast tumors
Time frame: Up to 32 weeks
The number of subjects with increased levels of DHA-containing and EPA-containing lipid species in primary breast tumors.
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 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Lubna Chaudhary, MD, MS principal investigator
Medical College of Wisconsin
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 Mini rTG OMEGA-3 Fish Oil in people with Breast Cancer, run by Medical College of Wisconsin 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 12 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Oct 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?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid species in primary breast tumors (time frame: Up to 32 weeks). 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 20 Oct 2026.