Locoregionally Recurrent Hormone-receptor Positive Breast CancerPhase 1NCT06745804
Study of 68Ga-R10602
A Phase 1 study testing 68Ga-R10602 injection in people with Locoregionally Recurrent Hormone-receptor Positive Breast Cancer and Metastatic Hormone Receptor Positive Breast Cancer, run by Radionetics Oncology at 6 sites in United States.
Trial summary
A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer, Hormone Receptor Positive Breast Adenocarcinoma
- What is being tested?
- 68Ga-R10602 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Dec 2024to 4 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast Cancer Eligibility:
- Population 1: Pathologically confirmed ER and/or PR positive, locoregionally recurrent or metastatic breast cancer that is refractory to endocrine therapy (progression on at least one line of endocrine therapy and determined by the investigator that Study Participant would not benefit from additional endocrine therapy) who have received at least one line of chemotherapy or antibody drug conjugate in the metastatic setting (recurrence within 6 months of adjuvant chemotherapy counts as one line of therapy). There is no limit on prior number of lines of endocrine therapy. Prior treatment with CDK4/6, AKT, PI3K and/or mTOR inhibitors is permitted.
- Population 2: Pathologically confirmed ER positive and HER2 negative locoregional or metastatic breast adenocarcinoma that is not amenable to resection, with progression on at least one line of prior endocrine therapy in the adjuvant or metastatic setting and starting next line of therapy that will include endocrine therapy, such as tamoxifen, fulvestrant, aromatase inhibitor, or elacestrant with or without ovarian suppression.
- Population 3: Study Participants with pathologically confirmed, estrogen and/or progesterone receptor (ER and/or PR) positive and HER2 negative breast adenocarcinoma who are ineligible for Population 1 or 2.
- At least one target or non-target lesion per RECIST 1.1
- Male or non-pregnant, non-lactating female Study Participant age ≥18 years. Female Study Participant of child-bearing potential and male Study Participant (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.
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- Medically acceptable adequate contraception for sexually active females with child-bearing potential include: 1) surgical sterilization (such as tubal ligation or hysterectomy), 2) approved hormonal contraceptives, 3) barrier method (such as condom or diaphragm) used with a spermicide, or 4) intrauterine device (IUD).
- Medically acceptable adequate contraception for sexually active males include: 1) surgical sterilization (such as vasectomy), 2) a condom used with a spermicide.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
- Adequate hepatic function as defined below (within 28 days of dosing with 68Ga R10602):
- Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present, and
- Serum bilirubin: total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN).
- Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL/minute), determined within 28 days of dosing with 68Ga-R10602.
- Able to understand and willing to sign an informed consent form (ICF).
Who cannot join
- Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R10602.
- Radiotherapy ≤14 days prior to dosing with 68Ga-R10602.
- Major surgery ≤21 days prior to dosing with 68Ga-R10602 or has not recovered from adverse effects of such procedure.
- Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
- History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
- Major active infection requiring antibiotics.
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- Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.
- Acute illness within 14 days prior to dosing with 68Ga-R10602 unless mild in severity, as assessed by the Investigator.
- Any other condition that in the opinion of the Investigator would place the Study Participant at an unacceptable risk or cause the Study Participant to be unlikely to fully participate or comply with study procedures.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan Medicine
Ann Arbor, Michigan, 48109
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 844112
About this study
Official title: Phase 1 Imaging Study of 68Ga-R10602-101 in Hormone Receptor-Positive Breast Cancer
A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer.
Read the detailed description
There are three eligible disease populations for the study. Population 1 are patients with metastatic or locoregionally recurrent, endocrine-resistant, ER+ and/or PR+ breast cancer who have received at least one line of chemotherapy or ADC. Population 2 are patients with ER+ and HER2- locoregional or metastatic non-resectable breast adenocarcinoma with progression on at least one line of prior endocrine therapy in the adjuvant or metastatic setting and starting next line of therapy that will include tamoxifen, fulvestrant, aromatase inhibitor, or elacestrant with or without ovarian suppression. Population 3 are patients with ER+ and/or PR+ and HER2- breast cancer who are ineligible for Population 1 or 2. All disease populations are eligible for both cohorts.
Cohort 1 will consist of three dose de-escalating cohorts with four patients each for a total of twelve patients. Once the twelve patients have completed the dose de-escalation, the three dose levels will be evaluated, and additional subjects may be enrolled into Cohort 1 at the single chosen dose. All patients will undergo imaging at a single timepoint and no dosimetry will be performed.
In Cohort 2, approximately six to eight patients will receive the single chosen dose followed by imaging at five timepoints and blood dosimetry at seven timepoints.
- Conditions
- Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer, Hormone Receptor Positive Breast Adenocarcinoma
- Being tested
- 68Ga-R10602 injection
- Keywords
- Hormone Receptor Positive Breast Cancer, Endocrine resistant, Radioisotope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-R10602 injectionDrug
68Ga-R10602 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions in hormone receptor positive breast cancer
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-R10602 Imaging Optimization Portion (Cohort 1) | Other | 68Ga-R10602 injection at pre-defined dose levels. PET/CT imaging at pre-defined timepoints. Receives: Drug: 68Ga-R10602 injection |
| 68Ga-R10602 Imaging Confirmation Portion (Cohort 2) | Other | 68Ga-R10602 injection at the selected dose level. PET/CT imaging at a single timepoint. Receives: Drug: 68Ga-R10602 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Measured: Day 1 to Day 7
Incidence of Serious Adverse Events
Number of participants with serious adverse events
Measured: Day 1 to Day 7
Incidence of Clinically Significant Lab Changes
Number of participants with clinically significant change in clinical laboratory parameters
Measured: Day 1 to Day 7
Secondary outcomes (12)
Number and location of tumors identified by 68Ga-R10602 PET/CT
Number of tumors identified by 68Ga-PET/CT per participant
Measured: 1 day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Location of tumors identified by 68Ga-10602 PET/CT per participants
Measured: 1 Day
Number and location of tumors identified by 68Ga-R10602 PET/CT
SUV max of tumor lesions per participant
Measured: 1 Day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Ratio of tumor SUV over reference regions SUV
Measured: 1 Day
Number and location of tumor lesions identified by 68Ga-R10602 PET/CT versus standard of care imaging
Number and location of tumor lesions identified by 68Ga-R10602 PET/CT and by standard of care imaging (e.g. contrast enhanced diagnostic CT) and concordance rate between 68Ga-R10602 PET/CT and standard of care images.
Measured: 1 day
Image quality
Image quality as assessed by a 5-point Likert scale by central review
Measured: 1 day
Absorbed dose coefficients and total body effective dose
Absorbed dose coefficients (milliGray [mGy]/megabecquerel [MBq]) in organs.
Measured: 1 day
Absorbed dose coefficients and total body effective dose
The total body effective dose (milliSievert [mSv]/MBq).
Measured: 1 Day
PK parameters
PK parameters, including Cmax
Measured: 1 day
PK parameters
PK parameters including area under the curve (AUC).
Measured: 1 Day
PK parameters
PK parameters including half-life (T1/2) in blood samples.
Measured: 1 Day
PK parameters
Other pharmacokinetic (PK) parameters may also be evaluated as needed to support the outcome measure.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start10 Dec 2024
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locoregionally Recurrent Hormone-receptor Positive Breast CancerStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radionetics Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745804
- Sponsor's protocol ID
- R10602-101
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Imaging Study of 68Ga-R10602-101 in Hormone Receptor-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT06745804
- Acronym / sponsor ID
- R10602-101
- Conditions
- Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer, Hormone Receptor Positive Breast Adenocarcinoma
- Keywords
- Hormone Receptor Positive Breast Cancer, Endocrine resistant, Radioisotope
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Radionetics OncologyIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 20 Dec 2024 (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.
A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer.
Detailed description
There are three eligible disease populations for the study. Population 1 are patients with metastatic or locoregionally recurrent, endocrine-resistant, ER+ and/or PR+ breast cancer who have received at least one line of chemotherapy or ADC. Population 2 are patients with ER+ and HER2- locoregional or metastatic non-resectable breast adenocarcinoma with progression on at least one line of prior endocrine therapy in the adjuvant or metastatic setting and starting next line of therapy that will include tamoxifen, fulvestrant, aromatase inhibitor, or elacestrant with or without ovarian suppression. Population 3 are patients with ER+ and/or PR+ and HER2- breast cancer who are ineligible for Population 1 or 2. All disease populations are eligible for both cohorts.
Cohort 1 will consist of three dose de-escalating cohorts with four patients each for a total of twelve patients. Once the twelve patients have completed the dose de-escalation, the three dose levels will be evaluated, and additional subjects may be enrolled into Cohort 1 at the single chosen dose. All patients will undergo imaging at a single timepoint and no dosimetry will be performed.
In Cohort 2, approximately six to eight patients will receive the single chosen dose followed by imaging at five timepoints and blood dosimetry at seven timepoints.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 68Ga-R10602 Imaging Optimization Portion (Cohort 1) | Other | Drug: 68Ga-R10602 injection68Ga-R10602 injection at pre-defined dose levels. PET/CT imaging at pre-defined timepoints. |
| 68Ga-R10602 Imaging Confirmation Portion (Cohort 2) | Other | Drug: 68Ga-R10602 injection68Ga-R10602 injection at the selected dose level. PET/CT imaging at a single timepoint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Breast Cancer Eligibility:
- At least one target or non-target lesion per RECIST 1.1
- Male or non-pregnant, non-lactating female Study Participant age ≥18 years. Female Study Participant of child-bearing potential and male Study Participant (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
- Adequate hepatic function as defined below (within 28 days of dosing with 68Ga R10602):
Key exclusion criteria (9 listed)
- Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R10602.
- Radiotherapy ≤14 days prior to dosing with 68Ga-R10602.
- Major surgery ≤21 days prior to dosing with 68Ga-R10602 or has not recovered from adverse effects of such procedure.
- Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
- History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
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 |
|---|---|---|
| 68Ga-R10602 injection68Ga-R10602 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions in hormone receptor positive breast cancer | Drug | 68Ga-R10602 Imaging Confirmation Portion (Cohort 2), 68Ga-R10602 Imaging Optimization Portion (Cohort 1) |
Primary outcome
Incidence of adverse events
Time frame: Day 1 to Day 7
Number of participants with adverse events as assessed by NCI-CTCAE v5.0, including grade
Incidence of Serious Adverse Events
Time frame: Day 1 to Day 7
Number of participants with serious adverse events
Incidence of Clinically Significant Lab Changes
Time frame: Day 1 to Day 7
Number of participants with clinically significant change in clinical laboratory parameters
12 secondary outcomes
Number and location of tumors identified by 68Ga-R10602 PET/CT
Time frame: 1 day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Time frame: 1 Day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Time frame: 1 Day
Number and location of tumors identified by 68Ga-R10602 PET/CT
Time frame: 1 Day
Number and location of tumor lesions identified by 68Ga-R10602 PET/CT versus standard of care imaging
Time frame: 1 day
Image quality
Time frame: 1 day
Absorbed dose coefficients and total body effective dose
Time frame: 1 day
Absorbed dose coefficients and total body effective dose
Time frame: 1 Day
PK parameters
Time frame: 1 day
PK parameters
Time frame: 1 Day
PK parameters
Time frame: 1 Day
PK parameters
Time frame: 1 Day
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 6 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-R10602 injection in people with Locoregionally Recurrent Hormone-receptor Positive Breast Cancer and Metastatic Hormone Receptor Positive Breast Cancer, run by Radionetics Oncology at 6 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 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: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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.
What does the primary outcome measure?
Incidence of adverse events (time frame: Day 1 to Day 7). The study lists 3 primary outcomes in all. 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 6 Jul 2026.