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Breast NeoplasmsPhase 2NCT04023292

Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer

A Phase 2 study testing Endocrine therapy in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Estrogen can promote proliferation of tumor cells in hormone receptors (HR)-positive breast cancer. The standard therapy of Luminal subtypes is endocrine therapy, which can influence proliferation of tumor cells by blocking the use of estrogen by cancer cells or lowering the amount of estrogen the body… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Endocrine therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
1 siteChina
Study dates
Jul 2019to Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed the informed consent.
  • Female aged between 18 and 70 years.
  • Pathologically diagnosed operable invasive breast cancer meeting the following criterias:
  • Hormone receptor (HR)-positive: pathologically diagnosed estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive;
  • Human epidermal growth factor receptor 2 (HER2)-negative: FISH or immunohistochemistry (IHC).
  • WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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  • Newly diagnosed breast cancer.
  • The important organ functions meet the following criterias:
  • WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.5×10^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL;
  • Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
  • Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine >= 60ml/min;
  • Thyroid stimulating hormone (TSH) <= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);
  • LVEF basement >= 50%.
  • Able to swallow tablets.
  • Pregnancy test (serum or urine HCG test within 72h before enrollment) must be negative in non-surgical sterilization or women of childbearing age, must be not for the nursing and be willing to take non-pharmacological contraception during treatment (such as intrauterine device, condom, etc).

Who cannot join

  • Evidence of distant metastasis.
  • Bilateral or multiple unilateral breast tumors with different histological characteristics (such as ER/PR/HER2 status, tumor grade or type, etc).
  • Any invasive malignancy diagnosed within previous 5 years (other than successfully treated cervical carcinoma in situ, skin basal cell carcinoma or cutaneous squamous cell carcinoma).
  • Prior radiotherapy, chemotherapy, endocrine therapy, targeted therapy etc.
  • Concurrent use of HRT or any other estrogen-containing medication (including vaginal estrogens) within 4 weeks.
  • Prior use of estrogen implants.
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  • Prior use of high-dose systemic corticosteroids (except as antiemetic treatment), immunotherapy, or biological response modifiers (e.g., interferon, etc).
  • Use of an unlicensed or other investigational drug within 4 weeks.
  • Any severe comorbidities, inability to give informed consent or unavailability for follow-up, including but not limited to any of the following:
  • Heart failure above NYHA class 2 level; high-risk uncontrollable arrhythmia; unstable angina pectoris; myocardial infarction within 1 year; valvular heart disease with clinically significance or requiring intervention.
  • Chronic obstructive pulmonary disease requires treatment.
  • Chronic liver disease (cirrhosis, chronic active hepatitis, etc).
  • Cerebrovascular accident occurred within 6 months.
  • Severe epilepsy or central nervous system diseases.
  • Hypertension which cannot be well controlled by antihypertensive drugs.
  • Abnormal coagulation, bleeding tendency, or receiving thrombolysis or anticoagulant therapy.
  • Chronic renal insufficiency.
  • Active infection.
  • Psychiatric disability, etc.
  • Pregnant or nursing females.

Trial locations and contacts

1 site in 1 country.

Shicheng Su, M.D., Ph.D. contact

+86 13631304227

sushch@mail.sysu.edu.cn

Erwei Song, M.D., Ph.D. contact

+86 13926477694

songew@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, 510120

    Shicheng Su, M.D.,Ph.D., +86 13631304227, sushch@mail.sysu.edu.cn

    Erwei Song, M.D.,Ph.D., +86 13926477694, songew@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

RATIONALE: Estrogen can promote proliferation of tumor cells in hormone receptors (HR)-positive breast cancer. The standard therapy of Luminal subtypes is endocrine therapy, which can influence proliferation of tumor cells by blocking the use of estrogen by cancer cells or lowering the amount of estrogen the body makes. Thus, markers of proliferation are candidate markers of efficacy after short-term (e.g., 2 weeks or 4 weeks) preoperative hormone therapy. Ki-67 is most commonly used among these markers. In contrast to the absolute value, the degree of Ki-67 changes which consider the baseline values would be better to reflect the sensitivity of therapy. It is not yet known whether the degree of Ki-67 changes after 2 weeks or 4 weeks presurgery endocrine therapy is different and which interval is more suitable to assess therapy sensitivity.

PURPOSE: This randomized phase II trial is studying to compare the degree of Ki-67 changes after 2 weeks or 4 weeks preoperative endocrine therapy and to determine a more appropriate interval to assess hormone therapy sensitivity in women who are undergoing surgery for HR-positive, Human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Being tested
Endocrine therapy
Keywords
Hormone receptors-positive breast neoplasms, preoperative endocrine therapy, Ki-67
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endocrine therapyDrug

    Also called tamoxifen, Letrozole, Anastrazole, Exemestane, etc.

    Use before surgery for 2 weeks. Choice of endocrine therapy is according to guidelines and centre policy.

  • Endocrine therapyDrug

    Also called tamoxifen, Letrozole, Anastrazole, Exemestane, etc.

    Use before surgery for 4 weeks. Choice of endocrine therapy is according to guidelines and centre policy.

Study groups in NCT04023292
Study groupRoleWhat they receive
Arm I (2 weeks preoperative endocrine therapy))ExperimentalPatients receive endocrine therapy before surgery for 2 weeks. Choice of endocrine therapy is according to guidelines and centre policy.
Receives: Drug: Endocrine therapy
Arm II (4 weeks preoperative endocrine therapy)Active comparatorPatients receive endocrine therapy before surgery for 4 weeks. Choice of endocrine therapy is according to guidelines and centre policy.
Receives: Drug: Endocrine therapy

What is being measured

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

  1. Percentage Change From Pre-treatment to Post-treatment in Ki-67 Labelling Index

    Ki-67 labelling index is calculated as the percentage of cells with Ki-67-positive nuclear immunostaining as measured by immunohistochemistry (IHC). Range 0-100. Percentage change from pre-treatment to post-treatment=[(Ki-67post - Ki-67pre)/Ki-67pre]x100%

    Measured: 2 weeks or 4 weeks endocrine treatment before surgery

Secondary outcomes (2)

  1. Disease Free Survival (DFS)

    Measured: 5 years post-randomisation

  2. Overall Survival (OS)

    Measured: 5 years post-randomisation

Timeline

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

  1. First posted17 Jul 2019
  2. Study startJul 2019 (estimated)
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

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
185 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04023292
Sponsor's protocol ID
2019-KY-051
Other IDs
ChiCTR1900024427
Status last verified
Jul 2019
First submitted
15 Jul 2019
Last updated
17 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Endocrine therapy in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

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 15 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 17 Jul 2019. 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 China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shicheng Su, M.D., Ph.D. (+86 13631304227, sushch@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Pre-treatment to Post-treatment in Ki-67 Labelling Index (time frame: 2 weeks or 4 weeks endocrine treatment before surgery). 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 NCT04023292.

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 17 Jul 2019.

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