Mammographic Breast DensityPhase 2CREMENCT04616430
Topical Endoxifen in Women
A Phase 2 study testing Topical endoxifen in people with Mammographic Breast Density, run by Atossa Therapeutics, Inc. at 1 site in Sweden.
Trial summary
Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the pilot trial was to estimate time to mammographic density change. The primary objective was to determine the effect size of the breast density change between topical placebo and two doses of topical endoxifen. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammographic Breast Density
- What is being tested?
- Topical endoxifen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 9 Apr 2018to 4 Sep 2019
- 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 40 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant in the Karma Cohort
- Attending the national mammography screening program, i.e., aged 40-74 and have performed a screening mammogram maximum 3 months prior to study inclusion
- Mammographic density ~4.5 % density (volumetric) measured by Volpara, at the screening mammogram performed in connection to baseline (maximum 3 months prior to inclusion). The threshold value of 4.5% corresponds to the clinical Bl-RADS score A
- Postmenopausal, defined as no period of menstruation during last 12 months independent of any hormonal treatment
- Informed consent must be signed before any study specific assessments are performed
Who cannot join
- Any previous or current diagnosis of breast cancer (including carcinoma in situ).
- Any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in situ cancer of the cervix.
- A history of major surgery of the breast, e.g., reduction or enlargement, which might affect density measurements.
- Mammographic Bl-RADS malignancy code 3, or above, at baseline mammography, or at mammography during time of treatment. Recall for additional examinations due to technical problems with the mammogram is accepted.
- Currently using estrogen and progesterone based hormone replacement therapy (oral or patches). Local estrogen treatment is accepted (ex. Vagifem).
- Non-medical approved drugs against hot-flashes including phytoestrogen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Karma CREME-1: A Double-blind, Placebo-controlled, Three-armed, Pilot Study of the Effects, Safety and Tolerability of Topical Endoxifen in Women Within the Karma Cohort
Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the pilot trial was to estimate time to mammographic density change. The primary objective was to determine the effect size of the breast density change between topical placebo and two doses of topical endoxifen.
- Conditions
- Mammographic Breast Density
- Being tested
- Topical endoxifen, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical endoxifenDrug
topical solution
PlaceboDrug
topical
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Topical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil Receives: Drug: Placebo |
| Topical Endoxifen 10mg/breast/day | Active comparator | 10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil Receives: Drug: Topical endoxifen |
| Topical Endoxifen 20mg/breast/day | Active comparator | 20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil Receives: Drug: Topical endoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mammographic Breast Density At Study Exit
Change, on an individual level, in mammographic breast density, measured at 6 months or when exiting from the study (baseline screening mammography)
Measured: From baseline to study exit up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start9 Apr 2018
- Primary completion10 Sep 2018
- Study completion4 Sep 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mammographic Breast DensityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atossa Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Per Hall, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616430
- Sponsor's protocol ID
- ATOS-010
- Acronym
- CREME
- Status last verified
- Jun 2021
- First submitted
- 16 Oct 2020
- Last updated
- 12 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Backlund M, Eriksson M, Gabrielson M, Hammarstrom M, Quay S, Bergqvist J, Hellgren R, Czene K, Hall P. Topical Endoxifen for Mammographic Density Reduction-A Randomized Controlled Trial. Oncologist. 2022 Jul 5;27(7):e597-e600. doi: 10.1093/oncolo/oyac102.
PubMed 35604960
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Karma CREME-1: A Double-blind, Placebo-controlled, Three-armed, Pilot Study of the Effects, Safety and Tolerability of Topical Endoxifen in Women Within the Karma Cohort
- ClinicalTrials.gov ID
- NCT04616430
- Acronym / sponsor ID
- CREME / ATOS-010
- Conditions
- Mammographic Breast Density
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Atossa Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the pilot trial was to estimate time to mammographic density change. The primary objective was to determine the effect size of the breast density change between topical placebo and two doses of topical endoxifen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboTopical Placebo:Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil |
| Topical Endoxifen 10mg/breast/day | Active comparator | Drug: Topical endoxifen10 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil |
| Topical Endoxifen 20mg/breast/day | Active comparator | Drug: Topical endoxifen20 mg/day topical (Z)-endoxifen; Transcutol™ (2-(2-Ethoxyethoxy)ethanol); isopropanol, Crodamol™ GTCC (a fully saturated emollient triester) and mineral oil |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant in the Karma Cohort
- Attending the national mammography screening program, i.e., aged 40-74 and have performed a screening mammogram maximum 3 months prior to study inclusion
- Mammographic density ~4.5 % density (volumetric) measured by Volpara, at the screening mammogram performed in connection to baseline (maximum 3 months prior to inclusion). The threshold value of 4.5% corresponds to the clinical Bl-RADS score A
- Postmenopausal, defined as no period of menstruation during last 12 months independent of any hormonal treatment
- Informed consent must be signed before any study specific assessments are performed
Key exclusion criteria (6 listed)
- Any previous or current diagnosis of breast cancer (including carcinoma in situ).
- Any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in situ cancer of the cervix.
- A history of major surgery of the breast, e.g., reduction or enlargement, which might affect density measurements.
- Mammographic Bl-RADS malignancy code 3, or above, at baseline mammography, or at mammography during time of treatment. Recall for additional examinations due to technical problems with the mammogram is accepted.
- Currently using estrogen and progesterone based hormone replacement therapy (oral or patches). Local estrogen treatment is accepted (ex. Vagifem).
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 |
|---|---|---|
| Topical endoxifentopical solution | Drug | Topical Endoxifen 10mg/breast/day, Topical Endoxifen 20mg/breast/day |
| Placebotopical | Drug | Control |
Primary outcome
Change in Mammographic Breast Density At Study Exit
Time frame: From baseline to study exit up to 6 months
Change, on an individual level, in mammographic breast density, measured at 6 months or when exiting from the study (baseline screening mammography)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35604960Backlund M, Eriksson M, Gabrielson M, Hammarstrom M, Quay S, Bergqvist J, Hellgren R, Czene K, Hall P. Topical Endoxifen for Mammographic Density Reduction-A Randomized Controlled Trial. Oncologist. 2022 Jul 5;27(7):e597-e600. doi: 10.1093/oncolo/oyac102.
- 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.
Per Hall, MD principal investigator
Karolinska Institutet
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 Topical endoxifen in people with Mammographic Breast Density, run by Atossa Therapeutics, Inc. at 1 site in Sweden.
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 5 inclusion and 6 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 12 Jul 2021. 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 Sweden. 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 18 Jun 2021). 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?
Change in Mammographic Breast Density At Study Exit (time frame: From baseline to study exit up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616430, which also lists 1 linked publication.
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 12 Jul 2021.