Comparing effects of short-term hormone therapy before surgery in breast cancer

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

This study tests whether two different lengths of hormone therapy before surgery can help women with hormone receptor-positive breast cancer by looking at changes in a tumor marker.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04023292 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the changes in the Ki-67 marker, which indicates tumor cell proliferation, after two different durations of preoperative endocrine therapy in women with hormone receptor-positive breast cancer. Participants will receive either 2 weeks or 4 weeks of endocrine therapy before surgery, and the study aims to determine which duration is more effective in assessing therapy sensitivity. The trial will involve measuring the degree of Ki-67 changes from baseline to evaluate the efficacy of the treatment. This research could provide insights into optimizing preoperative therapy for better patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 70 with operable, hormone receptor-positive, HER2-negative invasive breast cancer.

Not a fit: Patients with non-operable breast cancer or those with HER2-positive tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved preoperative treatment strategies for patients with hormone receptor-positive breast cancer.

How similar studies have performed: Other studies have shown promise in using Ki-67 as a marker for therapy sensitivity, making this approach both relevant and potentially impactful.

Eligibility 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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Shicheng Su, M.D., Ph.D.

Conditions Breast Neoplasms; Hormone receptors-positive breast neoplasms; preoperative endocrine therapy; Ki-67