Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04023292
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Shicheng Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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 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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Endocrine therapy Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm I (2 weeks preoperative endocrine therapy))
Patients receive endocrine therapy before surgery for 2 weeks. Choice of endocrine therapy is according to guidelines and centre policy.
Drug: Endocrine therapy
Use before surgery for 2 weeks. Choice of endocrine therapy is according to guidelines and centre policy.
Other Name: tamoxifen, Letrozole, Anastrazole, Exemestane, etc.

Active Comparator: Arm II (4 weeks preoperative endocrine therapy)
Patients receive endocrine therapy before surgery for 4 weeks. Choice of endocrine therapy is according to guidelines and centre policy.
Drug: Endocrine therapy
Use before surgery for 4 weeks. Choice of endocrine therapy is according to guidelines and centre policy.
Other Name: tamoxifen, Letrozole, Anastrazole, Exemestane, etc.




Primary Outcome Measures :
  1. Percentage Change From Pre-treatment to Post-treatment in Ki-67 Labelling Index [ Time Frame: 2 weeks or 4 weeks endocrine treatment before surgery ]
    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%


Secondary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: 5 years post-randomisation ]
  2. Overall Survival (OS) [ Time Frame: 5 years post-randomisation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed the informed consent.
  2. Female aged between 18 and 70 years.
  3. 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).
  4. WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  5. Newly diagnosed breast cancer.
  6. 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%.
  7. Able to swallow tablets.
  8. 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).

Exclusion Criteria:

  1. Evidence of distant metastasis.
  2. Bilateral or multiple unilateral breast tumors with different histological characteristics (such as ER/PR/HER2 status, tumor grade or type, etc).
  3. 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).
  4. Prior radiotherapy, chemotherapy, endocrine therapy, targeted therapy etc.
  5. Concurrent use of HRT or any other estrogen-containing medication (including vaginal estrogens) within 4 weeks.
  6. Prior use of estrogen implants.
  7. Prior use of high-dose systemic corticosteroids (except as antiemetic treatment), immunotherapy, or biological response modifiers (e.g., interferon, etc).
  8. Use of an unlicensed or other investigational drug within 4 weeks.
  9. 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.
  10. Pregnant or nursing females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023292


Contacts
Layout table for location contacts
Contact: Shicheng Su, M.D., Ph.D. +86 13631304227 sushch@mail.sysu.edu.cn
Contact: Erwei Song, M.D., Ph.D. +86 13926477694 songew@mail.sysu.edu.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Shicheng Su, M.D.,Ph.D.    +86 13631304227    sushch@mail.sysu.edu.cn   
Contact: Erwei Song, M.D.,Ph.D.    +86 13926477694    songew@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Layout table for additonal information
Responsible Party: Shicheng Su, Director of Shuhua Breast Cancer Research Center of Sun Yat-sen Memorial Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04023292     History of Changes
Other Study ID Numbers: 2019-KY-051
ChiCTR1900024427 ( Registry Identifier: Chinese Clinical Trial Registry )
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shicheng Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
Hormone receptors-positive breast neoplasms
preoperative endocrine therapy
Ki-67

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Tamoxifen
Letrozole
Exemestane
Anastrozole
Phenobarbital
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
GABA Modulators