Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country

A Phase 2 study testing Tamoxifen in people with Breast Cancer and Breast Neoplasms, run by Vanderbilt University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Breast Neoplasms
What is being tested?: Tamoxifen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: No sites listed yet
Study dates: Jan 2013to Sep 2014
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient evaluated and treated at INCAN
Patients must provide informed consent
Patient must be ≥ 18 years of age.
Life expectancy ≥ 6 months
Clinical locally advance breast cancer (Stage IIB or III)
Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score > 4
Patient must have an ECOG Performance Status of 0-2
Patients must be able to swallow and retain oral medication

Who cannot join

Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years
Patient must not be pregnant or nursing
Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
Women of childbearing age unable or unwilling to use contraception

About this study

Official title: Neoadjuvant Endocrine Therapy in Locally Advanced Hormone Receptor Positive Breast Cancer in a Low-Resource, Middle-Income Setting (Guatemala)

This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country.

Read the detailed description

This is a single arm feasibility study of neoadjuvant tamoxifen for locally advanced hormone receptor positive breast cancer in a low-resource setting in a middle-income country (Guatemala). Patients will be treated with tamoxifen for four to six weeks, then have an on-treatment biopsy to assess Ki-67. If Ki-67 is less than or equal to 10%, the patient will continue on tamoxifen for a total of 4 months; if Ki-67 is greater than 10% or there is clinical progression, patients will be taken off study. The study will evaluate the proportion of patients treated with four months of tamoxifen who undergo definitive surgery and the clinical and pathologic response rates.

Conditions: Breast Cancer, Breast Neoplasms
Being tested: Tamoxifen
Keywords: Breast neoplasms, Breast cancer, Locally advanced breast cancer, Neoadjuvant endocrine therapy, Tamoxifen, Low and middle income country
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
Tamoxifen 20mg by mouth daily

Study groups in NCT02806544
Study group	Role	What they receive
Tamoxifen	Experimental	Tamoxifen 20mg by mouth daily Receives: Drug: Tamoxifen

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility
Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.
Measured: 4-6 months

Secondary outcomes (5)

Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen
Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)
Measured: 4-6 months
Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy
Result is the number of participants who had Ki67 suppression (< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy.
Measured: 4-6 weeks
Overall Clinical Response Rate
Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes < 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response.
Measured: 4-6 months
Pathologic Complete Response
Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery.
Measured: 4-6 months
Breast Conserving Therapy
The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy).
Measured: 4-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Sep 2014

First posted20 Jun 2016 (estimated)
Study startJan 2013
Primary completionSep 2014
Study completionSep 2014

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02806544
Sponsor's protocol ID: 150045
Status last verified: Dec 2016
First submitted: 16 Jun 2016
Last updated: 30 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant Endocrine Therapy in Locally Advanced Hormone Receptor Positive Breast Cancer in a Low-Resource, Middle-Income Setting (Guatemala)
ClinicalTrials.gov ID: NCT02806544
Acronym / sponsor ID: 150045
Conditions: Breast Cancer, Breast Neoplasms
Keywords: Breast neoplasms, Breast cancer, Locally advanced breast cancer, Neoadjuvant endocrine therapy, Tamoxifen, Low and middle income country
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Collaborators: Washington University School of Medicine, Instituto National de Cancerologia, Guatemala
Study start: Jan 2013
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 20 Jun 2016 (estimated)
Results: Posted 17 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tamoxifen	Experimental	Drug: TamoxifenTamoxifen 20mg by mouth daily

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient evaluated and treated at INCAN
Patients must provide informed consent
Patient must be ≥ 18 years of age.
Life expectancy ≥ 6 months
Clinical locally advance breast cancer (Stage IIB or III)

Key exclusion criteria (4 listed)

Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years
Patient must not be pregnant or nursing
Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
Women of childbearing age unable or unwilling to use contraception

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
TamoxifenTamoxifen 20mg by mouth daily	Drug	Tamoxifen

Primary outcome

Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility
Time frame: 4-6 months
Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.

5 secondary outcomes

Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen
Time frame: 4-6 months
Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy
Time frame: 4-6 weeks
Overall Clinical Response Rate
Time frame: 4-6 months
Pathologic Complete Response
Time frame: 4-6 months
Breast Conserving Therapy
Time frame: 4-6 months

Results and safety

Results posted to the registry on 17 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tamoxifen	35	31

Primary outcome: Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility

Time frame: 4-6 months. Number. Unit: participants

Measure	Tamoxifen n = 50
Value	35

Population analysed: The number of patients analyzed was the accrual goal for number of participants and the outcome measure was the actual number of participants accrued. The outcome measure time frame is the maximum time each participant would be on study.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks - 6 months (time on tamoxifen prior to surgery). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tamoxifen	0 of 35 (0%)	0 of 35 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Laila Agrawal, MD principal investigator

Vanderbilt University

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tamoxifen in people with Breast Cancer and Breast Neoplasms, run by Vanderbilt University.

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 8 inclusion and 4 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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 17 Nov 2016). 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?

Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility (time frame: 4-6 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 NCT02806544.

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 30 Jan 2017.