Breast CancerPhase 2NCT02142959
RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
A Phase 2 study testing Omaveloxolone Lotion 0.5%, Omaveloxolone Lotion 3% and 3D conformal radiation therapy in people with Breast Cancer, run by Biogen at 27 sites in United States.
Trial summary
Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to its direct physical complications and the resulting impact on overall quality of life, it can also be a dose-limiting toxicity requiring… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Omaveloxolone Lotion 0.5%, Omaveloxolone Lotion 3% and 3D conformal radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 27 sitesUnited States
- Study dates
- 30 Jun 2014to 30 Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients (18 to 75 years of age, inclusive);
- Patients diagnosed with ductal carcinoma in situ or non-inflammatory breast adenocarcinoma who have been referred for post-operative radiotherapy and have had no prior radiation treatment to that breast;
- Patients planning to undergo 3D conformal radiation therapy to the whole breast (as part of breast-conservation therapy / lumpectomy) or chest wall (as part of post-mastectomy irradiation), with or without treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary), using one of the following treatment schedules:
- 45 - 50.4 Gy in 1.8 Gy per day, in addition to 10-16 Gy boost
- 46 - 50 Gy in 2 Gy per day, in addition to 10-16 Gy boost;
- Patients who received breast-conservation therapy / lumpectomy must be receiving ≥ 107% of the total radiation dose (calculated from the total radiation dose including boost) to any portion of the breast, based on radiation inhomogeneity, and/or have a breast volume ≥ 1200 cc;
Who cannot join
- Patients with Stage T4 or Stage IV breast cancer;
- Patients with prior radiation therapy to the breast treated in this study;
- Patients with type V or VI skin according to the Fitzpatrick scale;
- Patients with bilateral breast cancer;
- Patients receiving partial breast irradiation therapy;
- Patients with uncontrolled diabetes (HbA1c > 11.0%, historical values within 6 months of screening are acceptable);
Show all 12Show fewer
- Patients with collagen vascular disease or vasculitis;
- Patients with concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
- Patients with active bacterial, fungal or viral skin infections;
- Patients with known active hepatitis B or hepatitis C infection;
- Patients who intend to use any other topical cream, lotion or preparation applied to the radiation treatment area;
- Patients receiving concomitant chemotherapy during the course of the planned radiation treatment regimen. Patients are eligible if they are receiving sequential, neoadjuvant or adjuvant chemotherapy that is not anticipated to be delivered during the time course of the radiation treatment regimen.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
St. Vincent Anderson Regional Hospital Cancer Center
Anderson, Indiana, 46016
AnMed Health Cancer Center
Anderson, South Carolina, 29621
University of Colorado Hospital, Dept. of Radiation Oncology
Aurora, Colorado, 80045
Sanford Health
Bismarck, North Dakota, 58501
John B. Amos Cancer Center
Columbus, Georgia, 31904
Hughes Cancer Center
East Stroudsburg, Pennsylvania, 18301
Parkview Research Center
Fort Wayne, Indiana, 46845
Radiation Oncology Associates - Parkview Research Center
Fort Wayne, Indiana, 46845
CaroMont Health Comprehensive Cancer Center
Gastonia, North Carolina, 28054
Mayo Clinic - LaCrosse
La Crosse, Wisconsin, 54601
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Ironwood Cancer and Research Centers
Mesa, Arizona, 85206
Columbia St. Mary's
Milwaukee, Wisconsin, 53211
21st Century Oncology - Carolina Regional Cancer Center
Myrtle Beach, South Carolina, 29577
Norwalk Hospital
Norwalk, Connecticut, 06856
University of Nebraska Medical Center - Eppley Cancer Center
Omaha, Nebraska, 68198
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Arizona Cancer Center
Scottsdale, Arizona, 85258
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103
Sanford Research/USD
Sioux Falls, South Dakota, 57104
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628
Spartanburg Regional Medical Center - Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Cancer Care Northwest
Spokane, Washington, 99202
Mount Nittany Medical Center
State College, Pennsylvania, 16803
St. John Health System
Tulsa, Oklahoma, 74104
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled, Parallel-group Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of RTA 408 Lotion in the Treatment of Patients at Risk for Radiation Dermatitis
Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to its direct physical complications and the resulting impact on overall quality of life, it can also be a dose-limiting toxicity requiring changes to the prescribed course of radiation therapy. The most common strategy employed in an attempt to prevent or minimize radiation dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the area clean, and minimizing exposure to potential mechanical irritants, such as scratching and rough clothing. However, this strategy has been shown to lack clinically significant efficacy. Consequently, there is a clinical need for new treatments that are effective in protecting against radiotherapy-induced oxidative stress and the subsequent development of radiation dermatitis.
Based on data from previous studies in animals and humans, Reata believes that omaveloxolone (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology patients undergoing radiation therapy.
This randomized, double-blind, vehicle-controlled, parallel-group trial will study the efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3% and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is recommended.
- Conditions
- Breast Cancer
- Being tested
- Omaveloxolone Lotion 0.5%, Omaveloxolone Lotion 3%, Vehicle Lotion, 3D conformal radiation therapy
- Keywords
- RTA 408, RTA 408 Lotion, Breast cancer, Radiation therapy, Radiation dermatitis, Oxidative stress, Inflammation, omaveloxolone
- Medical subject headings
- Breast Neoplasms, Radiodermatitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omaveloxolone Lotion 0.5%Drug
Also called RTA 408 Lotion 0.5%
Omaveloxolone lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
Omaveloxolone Lotion 3%Drug
Also called RTA 408 Lotion 3%
Omaveloxolone lotion 3% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
Vehicle LotionDrug
Lotion vehicle manufactured to mimic RTA 408 lotion will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
3D conformal radiation therapyRadiation
45 50.4 Gy in 1.8 Gy per day, in addition to 10 - 16 Gy boost or 46 - 50 Gy in 2 Gy per day, in addition to 10 - 16 Gy boost, at the physician's discretion
| Study group | Role | What they receive |
|---|---|---|
| omaveloxolone (RTA 408) Lotion 0.5% | Experimental | Omaveloxolone Lotion at a fixed dose of 0.5% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks) Receives: Drug: Omaveloxolone Lotion 0.5%; Radiation: 3D conformal radiation therapy |
| omaveloxolone (RTA 408) Lotion 3% | Experimental | Omaveloxolone Lotion at a fixed dose of 3% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 19 weeks) Receives: Drug: Omaveloxolone Lotion 3%; Radiation: 3D conformal radiation therapy |
| Vehicle Lotion | Placebo comparator | Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks) Receives: Drug: Vehicle Lotion; Radiation: 3D conformal radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-averaged Effect on Radiation Dermatitis Grade Measured With Common Terminology Criteria for Adverse Events (CTCAE, v 4.03) Following 3D Conformal Radiation Therapy to the Breast Following Topical Application of Omaveloxolone Lotion or Lotion Vehicle
CTCAE Radiation dermatitis scoring:
Grade 0 = No radiation dermatitis; Grade 1 = Faint erythema or dry desquamation; Grade 2 = Moderate to brisk erythema, patchy moist desquamation, mostly confined to skin folds and creases, moderate edema; Grade 3 = Moist desquamation in areas other than skin folds and creases, bleeding induced by minor trauma or abrasion; Grade 4 = Life-threatening consequences, skin necrosis or ulceration of full thickness dermis, spontaneous bleeding from involved site, skin graft indicated; Grade 5 = Death
Measured: Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study start30 Jun 2014
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142959
- Sponsor's protocol ID
- RTA 408-C-1306
- Status last verified
- May 2025
- First submitted
- 16 May 2014
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled, Parallel-group Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of RTA 408 Lotion in the Treatment of Patients at Risk for Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT02142959
- Acronym / sponsor ID
- RTA 408-C-1306
- Conditions
- Breast Cancer
- Keywords
- RTA 408, RTA 408 Lotion, Breast cancer, Radiation therapy, Radiation dermatitis, Oxidative stress, Inflammation, omaveloxolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to its direct physical complications and the resulting impact on overall quality of life, it can also be a dose-limiting toxicity requiring changes to the prescribed course of radiation therapy. The most common strategy employed in an attempt to prevent or minimize radiation dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the area clean, and minimizing exposure to potential mechanical irritants, such as scratching and rough clothing. However, this strategy has been shown to lack clinically significant efficacy. Consequently, there is a clinical need for new treatments that are effective in protecting against radiotherapy-induced oxidative stress and the subsequent development of radiation dermatitis.
Based on data from previous studies in animals and humans, Reata believes that omaveloxolone (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology patients undergoing radiation therapy.
This randomized, double-blind, vehicle-controlled, parallel-group trial will study the efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3% and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is recommended.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| omaveloxolone (RTA 408) Lotion 0.5% | Experimental | Drug: Omaveloxolone Lotion 0.5%, Radiation: 3D conformal radiation therapyOmaveloxolone Lotion at a fixed dose of 0.5% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks) |
| omaveloxolone (RTA 408) Lotion 3% | Experimental | Drug: Omaveloxolone Lotion 3%, Radiation: 3D conformal radiation therapyOmaveloxolone Lotion at a fixed dose of 3% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 19 weeks) |
| Vehicle Lotion | Placebo comparator | Drug: Vehicle Lotion, Radiation: 3D conformal radiation therapyVehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult female patients (18 to 75 years of age, inclusive);
- Patients diagnosed with ductal carcinoma in situ or non-inflammatory breast adenocarcinoma who have been referred for post-operative radiotherapy and have had no prior radiation treatment to that breast;
- Patients planning to undergo 3D conformal radiation therapy to the whole breast (as part of breast-conservation therapy / lumpectomy) or chest wall (as part of post-mastectomy irradiation), with or without treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary), using one of the following treatment schedules:
- Patients who received breast-conservation therapy / lumpectomy must be receiving ≥ 107% of the total radiation dose (calculated from the total radiation dose including boost) to any portion of the breast, based on radiation inhomogeneity, and/or have a breast volume ≥ 1200 cc;
Key exclusion criteria (12 listed)
- Patients with Stage T4 or Stage IV breast cancer;
- Patients with prior radiation therapy to the breast treated in this study;
- Patients with type V or VI skin according to the Fitzpatrick scale;
- Patients with bilateral breast cancer;
- Patients receiving partial breast irradiation therapy;
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 |
|---|---|---|
| Omaveloxolone Lotion 0.5%Also: RTA 408 Lotion 0.5%Omaveloxolone lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy | Drug | omaveloxolone (RTA 408) Lotion 0.5% |
| Omaveloxolone Lotion 3%Also: RTA 408 Lotion 3%Omaveloxolone lotion 3% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy | Drug | omaveloxolone (RTA 408) Lotion 3% |
| Vehicle LotionLotion vehicle manufactured to mimic RTA 408 lotion will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy | Drug | Vehicle Lotion |
| 3D conformal radiation therapy45 50.4 Gy in 1.8 Gy per day, in addition to 10 - 16 Gy boost or 46 - 50 Gy in 2 Gy per day, in addition to 10 - 16 Gy boost, at the physician's discretion | Radiation | Vehicle Lotion, omaveloxolone (RTA 408) Lotion 0.5%, omaveloxolone (RTA 408) Lotion 3% |
Primary outcome
Time-averaged Effect on Radiation Dermatitis Grade Measured With Common Terminology Criteria for Adverse Events (CTCAE, v 4.03) Following 3D Conformal Radiation Therapy to the Breast Following Topical Application of Omaveloxolone Lotion or Lotion Vehicle
Time frame: Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reported
CTCAE Radiation dermatitis scoring: Grade 0 = No radiation dermatitis; Grade 1 = Faint erythema or dry desquamation; Grade 2 = Moderate to brisk erythema, patchy moist desquamation, mostly confined to skin folds and creases, moderate edema; Grade 3 = Moist desquamation in areas other than skin folds and creases, bleeding induced by minor trauma or abrasion; Grade 4 = Life-threatening consequences, skin necrosis or ulceration of full thickness dermis, spontaneous bleeding from involved site, skin graft indicated; Grade 5 = Death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
27 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 Omaveloxolone Lotion 0.5%, Omaveloxolone Lotion 3% and 3D conformal radiation therapy in people with Breast Cancer, run by Biogen at 27 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 6 inclusion and 12 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 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-averaged Effect on Radiation Dermatitis Grade Measured With Common Terminology Criteria for Adverse Events (CTCAE, v 4.03) Following 3D Conformal Radiation Therapy to the Breast Following Topical Application of Omaveloxolone Lotion or Lotion Vehicle (time frame: Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reported). 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 3 Jun 2025.