Breast CancerPhase 2NCT02206984
Endocrine Response in Women With Invasive Lobular Breast Cancer
A Phase 2 study testing Tamoxifen, Anastrozole and Fulvestrant in people with Breast Cancer, run by Priscilla McAuliffe at 12 sites in United States.
Trial summary
RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen, Anastrozole and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 12 sitesUnited States
- Study dates
- 30 Sep 2015to 19 Jul 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed invasive lobular breast cancer, that is hormone receptor-positive and HER2-negative, measuring at least 1 centimeter (cm) radiographically or clinically, clinical stages I-III. Invasive lobular histology will be diagnosed at the enrolling institution for purposes of study participation. Subsequently, invasive lobular histology will be confirmed by central pathology review, but this central review will not be required prior to patient enrollment.
- Prior to initiation of study agents, study participants will be highly encouraged to undergo a baseline research core biopsy of their breast tumor. If this is not possible or the patient refuses, the pre-treatment tumor sample must be obtained from their archival diagnostic core biopsy. If definitive surgery is not performed at day 21-27 after study treatment, a second post-treatment research core biopsy will need to be obtained from their breast tumor. For patients undergoing surgery, the second biopsy will be removed from the breast tumor tissue excised during their operation. Note: In the event that the baseline breast tumor biopsy performed for research purposes does not yield adequate tumor tissue for analysis of the primary and secondary endpoints, tissue will be requested from the patient's archival clinical diagnostic core biopsy if it is available.The patient will still remain on study and complete protocol therapy as planned in this unlikely event.
- Hormone receptor (HR) status of the invasive component must be documented before trial enrollment. The tumor must be HR-positive. HR will be considered positive if staining is 1% or greater for ER and/or PR. This will be determined at the enrolling institution for purposes of study participation and enrollment onto the trial. Subsequently, HR status will be confirmed by central pathology review, but this central review will not be required prior to enrolling the patient. HER2 status will be determined locally only, based upon current ASCO/CAP guidelines.
- Patients must be female.
- Participants must be fully postmenopausal.
- ECOG performance status of 0, 1 or 2.
Show all 9Show fewer
- Adequate organ and marrow function as defined by a history and physical exam that rules out comorbidities that would be exclusions to participation in the study (see exclusion criteria) and clinical laboratory parameters as deemed clinically appropriate by the treating physician.
- Prior use of hormone contraceptives and replacement therapy is allowed (e.g., estrogen and/or progestin), but must have been discontinued at least 30 days prior to the study enrollment. Vaginal preparations (e.g., Vagifem® or Estring®)
- Participant must be aware of the nature of her malignancy, understand the study requirements and risks and be able and willing to sign a written informed consent document.
Who cannot join
- Prior or concurrent use of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer, including any history of prior irradiation to the ipsilateral breast. Additionally, the patient must not have had hormonal therapy for breast cancer treatment or for breast cancer prevention within 2 years prior to study enrollment. (Note: Synchronous breast, cancer (including bilateral breast cancer) at separate sites is permissible, provided the patient does not receive medical treatments for breast cancer or radiation therapy to the ipsilateral breast during the 21 day study intervention period.
- Concurrent use of any other investigational agents.
- History of allergic reactions/hypersensitivity attributed to compounds of similar chemical or biologic composition to tamoxifen, anastrozole, or fulvestrant or any of their ingredients.
- History of thromboembolic disease or uterine cancer that is considered a contraindication to tamoxifen.
- Active hepatitis viral infections or a known history of liver disease, especially moderate (Child-Pugh Class B) to severe (Child-Pugh Class C) hepatic impairment.
- Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- HER-2 positivity.
- Increased Risk of bleeding: including a history of a bleeding diathesis and/or known history of severe thrombocytopenia. NOTE: Anticoagulant use is not a contraindication to fulvestrant, but caution is advised in administration in patients on anticoagulation. Patients on anticoagulation who will receive fulvestrant will have PT and aPTT/INR assessed at baseline.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
University of Chicago Medical Center
Chicago, Illinois, 60637
Lester and Sue Smith Breast Center, Baylor College of Medicine
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77064
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Josh Plassmeyer
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Univ. of Washington, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
ALBERT EINSTEIN COLLEGE OF MEDICINE Montefiore Medical Center
The Bronx, New York, 10467
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer
RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma are treated no differently than patients with invasive ductal carcinoma based on the void of information specific to patients with this tumor type. Identification of a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC patients would have dramatic implications for the future management of this breast cancer subtype.
PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as a surrogate for outcome of ILC patients on endocrine therapy.
Read more
Primary Objective:
To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).
Read the detailed description
OBJECTIVES
Primary
To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).
Secondary
- To evaluate ER protein expression in ILC tissues at baseline and following neoadjuvant endocrine therapy.
- To evaluate PR protein expression in ILC tissues at baseline and following neo-adjuvant endocrine therapy.
- To evaluate ER-related and ILC-specific candidate gene mRNA expression in ILC tissues at baseline and following neoadjuvant endocrine therapy in an effort to identify biomarkers of endocrine response and putative drivers of endocrine resistance in ILC.
- To evaluate associations between changes in Ki67 in ILC tissues following neoadjuvant endocrine therapy with ER and PR protein expression, or ER and candidate gene mRNA expression at baseline and post-treatment.
Exploratory
- To evaluate DNA methylation in ILC tissues at baseline and following neo-adjuvant endocrine therapy.
- To evaluate associations between germline and somatic DNA sequence variants with changes in Ki67 in ILC tissues following neo-adjuvant endocrine therapy.
- To evaluate the activity of signaling pathways in ILC tissues by immunohistochemical or other protein analyses, such as histone modifications, at baseline and following neo-adjuvant endocrine therapy.
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen, Anastrozole, Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
AnastrozoleDrug
FulvestrantDrug
| Study group | Role | What they receive |
|---|---|---|
| tamoxifen | Active comparator | Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days Receives: Drug: Tamoxifen |
| Anastrozole | Active comparator | 1mg given orally daily for 21 days Receives: Drug: Anastrozole |
| fulvestrant | Active comparator | 500 mg, administered as two 250 mg IM injections, given on days 1 and 14 Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Log-transformed Ki67 Proliferative Index
Ki67 expression is a routine pathologic marker that is strongly associated with cell proliferation. It is extensively used as a prognostic and predictive marker in cancer. Ki67 was calculated as a percentage of 1000 tumor cells counted in both the pre- and post-treatment specimens.
The primary endpoint was change in log-transformed Ki67 at post-treatment compared to baseline. We used fixed paired differences with mean (SD) log (post/pre).
Measured: Baseline, Day 21-27
Secondary outcomes (6)
Pre-treatment Ki67 Proliferative Index
Ki67 expression is a routine pathologic marker that is strongly associated with cell proliferation. It is extensively used as a prognostic and predictive marker in cancer. Ki67 was calculated as a percentage of 1000 tumor cells counted in both the pre- and post-treatment specimens.
Measured: Baseline
Post-treatment Ki67 Proliferative Index
Ki67 expression is a routine pathologic marker that is strongly associated with cell proliferation. It is extensively used as a prognostic and predictive marker in cancer. Ki67 was calculated as a percentage of 1000 tumor cells counted in both the pre- and post-treatment specimens.
Measured: Day 21-27
Pre-treatment Estrogen Receptor H Score
Estrogen receptor (ER) Histologic (H) Score is calculated as the sum of intensity of staining (0 to 3+) multiplied by the proportion (%) of cells staining positive and has a dynamic range of 0 to 300. ER H score pre-treatment was determined for each of the three treatment groups.
Measured: Baseline
Post-treatment Estrogen Receptor (ER) H Score
Estrogen receptor (ER) Histologic (H) Score is calculated as the sum of intensity of staining (0 to 3+) multiplied by the proportion (%) of cells staining positive and has a dynamic range of 0 to 300. ER H score was determined in each of the three post treatment groups.
Measured: Day 21-27
Pre-treatment Progesterone Receptor (PR) H Score
Progesterone receptor (PR) Histologic (H) Score is calculated as the sum of intensity of staining (0 to 3+) multiplied by the proportion (%) of cells staining positive and has a dynamic range of 0 to 300. PR H Score was determined at baseline.
Measured: Baseline
Post-treatment Progesterone Receptor (PR) H Score
Progesterone receptor (PR) Histologic (H) Score is calculated as the sum of intensity of staining (0 to 3+) multiplied by the proportion (%) of cells staining positive and has a dynamic range of 0 to 300. PR H score was determined post treatment.
Measured: Day 21-27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study start30 Sep 2015
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
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.
- 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
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Priscilla McAuliffe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Priscilla McAuliffe, University of Pittsburgh
- Investigators
- Priscilla McAuliffe, MD, Principal investigator, UPMC Magee Womens Hopspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206984
- Sponsor's protocol ID
- HCC 13-164 (ILC)
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2014
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sottnik JL, Bordeaux EK, Mehrotra S, Ferrara SE, Goodspeed AE, Costello JC, Sikora MJ. Mediator of DNA Damage Checkpoint 1 (MDC1) Is a Novel Estrogen Receptor Coregulator in Invasive Lobular Carcinoma of the Breast. Mol Cancer Res. 2021 Aug;19(8):1270-1282. doi: 10.1158/1541-7786.MCR-21-0025. Epub 2021 May 4.
PubMed 33947745
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer
- ClinicalTrials.gov ID
- NCT02206984
- Acronym / sponsor ID
- HCC 13-164 (ILC)
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Priscilla McAuliffeUniversity, hospital or other
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Posted 7 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma are treated no differently than patients with invasive ductal carcinoma based on the void of information specific to patients with this tumor type. Identification of a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC patients would have dramatic implications for the future management of this breast cancer subtype.
PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as a surrogate for outcome of ILC patients on endocrine therapy.
Primary Objective:
To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).
Detailed description
OBJECTIVES
Primary
To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).
Secondary
- To evaluate ER protein expression in ILC tissues at baseline and following neoadjuvant endocrine therapy.
- To evaluate PR protein expression in ILC tissues at baseline and following neo-adjuvant endocrine therapy.
- To evaluate ER-related and ILC-specific candidate gene mRNA expression in ILC tissues at baseline and following neoadjuvant endocrine therapy in an effort to identify biomarkers of endocrine response and putative drivers of endocrine resistance in ILC.
- To evaluate associations between changes in Ki67 in ILC tissues following neoadjuvant endocrine therapy with ER and PR protein expression, or ER and candidate gene mRNA expression at baseline and post-treatment.
Exploratory
- To evaluate DNA methylation in ILC tissues at baseline and following neo-adjuvant endocrine therapy.
- To evaluate associations between germline and somatic DNA sequence variants with changes in Ki67 in ILC tissues following neo-adjuvant endocrine therapy.
- To evaluate the activity of signaling pathways in ILC tissues by immunohistochemical or other protein analyses, such as histone modifications, at baseline and following neo-adjuvant endocrine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tamoxifen | Active comparator | Drug: TamoxifenTamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days |
| Anastrozole | Active comparator | Drug: Anastrozole1mg given orally daily for 21 days |
| fulvestrant | Active comparator | Drug: Fulvestrant500 mg, administered as two 250 mg IM injections, given on days 1 and 14 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed invasive lobular breast cancer, that is hormone receptor-positive and HER2-negative, measuring at least 1 centimeter (cm) radiographically or clinically, clinical stages I-III. Invasive lobular histology will be diagnosed at the enrolling institution for purposes of study participation. Subsequently, invasive lobular histology will be confirmed by central pathology review, but this central review will not be required prior to patient enrollment.
- Prior to initiation of study agents, study participants will be highly encouraged to undergo a baseline research core biopsy of their breast tumor. If this is not possible or the patient refuses, the pre-treatment tumor sample must be obtained from their archival diagnostic core biopsy. If definitive surgery is not performed at day 21-27 after study treatment, a second post-treatment research core biopsy will need to be obtained from their breast tumor. For patients undergoing surgery, the second biopsy will be removed from the breast tumor tissue excised during their operation. Note: In the event that the baseline breast tumor biopsy performed for research purposes does not yield adequate tumor tissue for analysis of the primary and secondary endpoints, tissue will be requested from the patient's archival clinical diagnostic core biopsy if it is available.The patient will still remain on study and complete protocol therapy as planned in this unlikely event.
- Hormone receptor (HR) status of the invasive component must be documented before trial enrollment. The tumor must be HR-positive. HR will be considered positive if staining is 1% or greater for ER and/or PR. This will be determined at the enrolling institution for purposes of study participation and enrollment onto the trial. Subsequently, HR status will be confirmed by central pathology review, but this central review will not be required prior to enrolling the patient. HER2 status will be determined locally only, based upon current ASCO/CAP guidelines.
- Patients must be female.
- Participants must be fully postmenopausal.
Key exclusion criteria (8 listed)
- Prior or concurrent use of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer, including any history of prior irradiation to the ipsilateral breast. Additionally, the patient must not have had hormonal therapy for breast cancer treatment or for breast cancer prevention within 2 years prior to study enrollment. (Note: Synchronous breast, cancer (including bilateral breast cancer) at separate sites is permissible, provided the patient does not receive medical treatments for breast cancer or radiation therapy to the ipsilateral breast during the 21 day study intervention period.
- Concurrent use of any other investigational agents.
- History of allergic reactions/hypersensitivity attributed to compounds of similar chemical or biologic composition to tamoxifen, anastrozole, or fulvestrant or any of their ingredients.
- History of thromboembolic disease or uterine cancer that is considered a contraindication to tamoxifen.
- Active hepatitis viral infections or a known history of liver disease, especially moderate (Child-Pugh Class B) to severe (Child-Pugh Class C) hepatic impairment.
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 | Drug | tamoxifen |
| Anastrozole | Drug | Anastrozole |
| Fulvestrant | Drug | fulvestrant |
Primary outcome
Change in Log-transformed Ki67 Proliferative Index
Time frame: Baseline, Day 21-27
Ki67 expression is a routine pathologic marker that is strongly associated with cell proliferation. It is extensively used as a prognostic and predictive marker in cancer. Ki67 was calculated as a percentage of 1000 tumor cells counted in both the pre- and post-treatment specimens. The primary endpoint was change in log-transformed Ki67 at post-treatment compared to baseline. We used fixed paired differences with mean (SD) log (post/pre).
6 secondary outcomes
Pre-treatment Ki67 Proliferative Index
Time frame: Baseline
Post-treatment Ki67 Proliferative Index
Time frame: Day 21-27
Pre-treatment Estrogen Receptor H Score
Time frame: Baseline
Post-treatment Estrogen Receptor (ER) H Score
Time frame: Day 21-27
Pre-treatment Progesterone Receptor (PR) H Score
Time frame: Baseline
Post-treatment Progesterone Receptor (PR) H Score
Time frame: Day 21-27
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33947745Sottnik JL, Bordeaux EK, Mehrotra S, Ferrara SE, Goodspeed AE, Costello JC, Sikora MJ. Mediator of DNA Damage Checkpoint 1 (MDC1) Is a Novel Estrogen Receptor Coregulator in Invasive Lobular Carcinoma of the Breast. Mol Cancer Res. 2021 Aug;19(8):1270-1282. doi: 10.1158/1541-7786.MCR-21-0025. Epub 2021 May 4.
- 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.
Priscilla McAuliffe, MD principal investigator
UPMC Magee Womens Hopspital
12 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 Tamoxifen, Anastrozole and Fulvestrant in people with Breast Cancer, run by Priscilla McAuliffe at 12 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 9 inclusion and 8 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 Aug 2026). 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 Log-transformed Ki67 Proliferative Index (time frame: Baseline, Day 21-27). 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 NCT02206984, 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 Aug 2026.