Breast CancerPhase 2NCT04129216
The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
A Phase 2 study testing Tamoxifen Citrate, Letrozole and Exemestane in people with Breast Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen Citrate, Letrozole and Exemestane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2019to 10 Nov 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment-naïve, histologically confirmed invasive ductal breast cancer between stages 1 to 3.
- Co-enrollment in the FLEX Registry
- Estrogen Receptor Positive (ER+) Progesterone Receptor Positive (PR+) confirmed hormone receptor status measured by immunohistochemistry (IHC)
- Patients should understand patients' condition and be able to give informed consent to participate
Who cannot join
- History of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer.
- Allergic reactions/hypersensitivity to tamoxifen, letrozole, or exemestane or any of the ingredients of these drugs.
- Any contraindication to hormonal therapy, such as history of thromboembolic disease or uterine cancer.
- Patients without invasive disease (stage 0)
- Patients with metastatic breast cancer(stageIV)
- Patients that are Human Epidermal Growth Factor 2+(HER2+) by IHC/Fluorescence in situ hybridization (FISH).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Hospital
Baltimore, Maryland, 21224
About this study
The investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.
Read the detailed description
Breast cancer is among the most common malignancies in women in the United States. Over the years breast cancer management have dramatically developed from the extensive surgical approach toward the breast conservative approach. This was mainly due to the introduction of chemotherapy and hormonal therapy. Hormonal therapy in particular has been shown to improve the oncological outcomes of the breast cancer. However, while this is well documented in the clinical outcomes. Little is known in regards what happens on the genetic level. As such in this study the investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.
The hypothesis of this study is that short-term, preoperative hormonal treatment will induce genetic changes associated with reduced proliferation, including lower Ki67 expression, and changes in Estrogen Receptor (ER) and Progesterone Receptor (PR) expression. The data from such investigation will be very helpful in advancing the individualized care to women with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen Citrate, Letrozole, Exemestane, Blueprint, Mammaprint
- Keywords
- breast cancer, genomic assay, hormone therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen CitrateDrug
Also called Soltamox
10mg administered daily. Patients take this drug for 2-6 weeks
LetrozoleDrug
Also called Femara
2.5mg is administered daily. Patients take this drug for 2-6 weeks
ExemestaneDrug
Also called Aromasin
25mg is administered daily. Patients take this drug for 2-6 weeks.
BlueprintDiagnostic test
studies the genomics of the tumor and tumor behavior
MammaprintDiagnostic test
studies the genomics of the tumor
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen arm | Experimental | for premenopausal patients Receives: Drug: Tamoxifen Citrate; Diagnostic Test: Blueprint; Diagnostic Test: Mammaprint |
| Letrozole arm | Experimental | for postmenopausal patients Receives: Drug: Letrozole; Diagnostic Test: Blueprint; Diagnostic Test: Mammaprint |
| Exemestane arm | Experimental | for postmenopausal patients Receives: Drug: Exemestane; Diagnostic Test: Blueprint; Diagnostic Test: Mammaprint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)
This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.
Measured: Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy
Secondary outcomes (3)
Number of Participants With Low or High Score in MammaPrint
Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence).
Measured: Baseline and at Time of surgery (up to 6 weeks)
Median Percent of Tissue ER Positive
Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC)
Measured: Baseline and at Time of surgery (up to 6 weeks)
Median Percent of Tissue PR Positive
Median percent of tissue PR positive in matched tissue measured by Immunohistochemistry (IHC)
Measured: Baseline and at Time of surgery (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start20 Feb 2019
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will start the hormone therapy before surgery; the investigators look for the genomic profiles of the tumor before and after chemotherapy
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Agendia
- Responsible party
- Sponsor
- Investigators
- Mehran Habibi, MD, Principal investigator, Johns Hopkins Bayview
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129216
- Sponsor's protocol ID
- IRB00130428
- Status last verified
- Apr 2024
- First submitted
- 17 May 2019
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Suman VJ, Ellis MJ, Ma CX. The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer. Chin Clin Oncol. 2015 Sep;4(3):34. doi: 10.3978/j.issn.2304-3865.2015.09.01.
PubMed 26408301
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
- ClinicalTrials.gov ID
- NCT04129216
- Acronym / sponsor ID
- IRB00130428
- Conditions
- Breast Cancer
- Keywords
- breast cancer, genomic assay, hormone therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Agendia
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 7 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.
Detailed description
Breast cancer is among the most common malignancies in women in the United States. Over the years breast cancer management have dramatically developed from the extensive surgical approach toward the breast conservative approach. This was mainly due to the introduction of chemotherapy and hormonal therapy. Hormonal therapy in particular has been shown to improve the oncological outcomes of the breast cancer. However, while this is well documented in the clinical outcomes. Little is known in regards what happens on the genetic level. As such in this study the investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.
The hypothesis of this study is that short-term, preoperative hormonal treatment will induce genetic changes associated with reduced proliferation, including lower Ki67 expression, and changes in Estrogen Receptor (ER) and Progesterone Receptor (PR) expression. The data from such investigation will be very helpful in advancing the individualized care to women with breast cancer.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will start the hormone therapy before surgery; the investigators look for the genomic profiles of the tumor before and after chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen arm | Experimental | Drug: Tamoxifen Citrate, Diagnostic Test: Blueprint, Diagnostic Test: Mammaprintfor premenopausal patients |
| Letrozole arm | Experimental | Drug: Letrozole, Diagnostic Test: Blueprint, Diagnostic Test: Mammaprintfor postmenopausal patients |
| Exemestane arm | Experimental | Drug: Exemestane, Diagnostic Test: Blueprint, Diagnostic Test: Mammaprintfor postmenopausal patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Treatment-naïve, histologically confirmed invasive ductal breast cancer between stages 1 to 3.
- Co-enrollment in the FLEX Registry
- Estrogen Receptor Positive (ER+) Progesterone Receptor Positive (PR+) confirmed hormone receptor status measured by immunohistochemistry (IHC)
- Patients should understand patients' condition and be able to give informed consent to participate
Key exclusion criteria (6 listed)
- History of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer.
- Allergic reactions/hypersensitivity to tamoxifen, letrozole, or exemestane or any of the ingredients of these drugs.
- Any contraindication to hormonal therapy, such as history of thromboembolic disease or uterine cancer.
- Patients without invasive disease (stage 0)
- Patients with metastatic breast cancer(stageIV)
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 |
|---|---|---|
| Tamoxifen CitrateAlso: Soltamox10mg administered daily. Patients take this drug for 2-6 weeks | Drug | Tamoxifen arm |
| LetrozoleAlso: Femara2.5mg is administered daily. Patients take this drug for 2-6 weeks | Drug | Letrozole arm |
| ExemestaneAlso: Aromasin25mg is administered daily. Patients take this drug for 2-6 weeks. | Drug | Exemestane arm |
| Blueprintstudies the genomics of the tumor and tumor behavior | Diagnostic test | Exemestane arm, Letrozole arm, Tamoxifen arm |
| Mammaprintstudies the genomics of the tumor | Diagnostic test | Exemestane arm, Letrozole arm, Tamoxifen arm |
Primary outcome
Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)
Time frame: Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy
This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.
3 secondary outcomes
Number of Participants With Low or High Score in MammaPrint
Time frame: Baseline and at Time of surgery (up to 6 weeks)
Median Percent of Tissue ER Positive
Time frame: Baseline and at Time of surgery (up to 6 weeks)
Median Percent of Tissue PR Positive
Time frame: Baseline and at Time of surgery (up to 6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26408301Suman VJ, Ellis MJ, Ma CX. The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer. Chin Clin Oncol. 2015 Sep;4(3):34. doi: 10.3978/j.issn.2304-3865.2015.09.01.
- 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.
Mehran Habibi, MD principal investigator
Johns Hopkins Bayview
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 Tamoxifen Citrate, Letrozole and Exemestane in people with Breast Cancer, run by Johns Hopkins University 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 4 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 7 May 2024. 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?
Yes. Results are posted in the registry (first posted 7 May 2024). 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 Percent Expression of Ki67 Measured by Immunohistochemistry (IHC) (time frame: Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy). 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 NCT04129216, 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 7 May 2024.