Clinical Trials /

Fasting on Newly Diagnosed Breast Cancer

NCT02379585

Description:

This study is to see how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while receiving chemotherapy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer
  • Official Title: A Pilot Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer (STEFNE Study)

Clinical Trial IDs

  • ORG STUDY ID: 1145332
  • NCT ID: NCT02379585

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
DoxorubicinDiagnosed with HER2 negative breast cancer
cyclophosphamideDiagnosed with HER2 negative breast cancer
paclitaxelDiagnosed with HER2 negative breast cancer
docetaxeldiagnosed with HER2 positive breast cancer
Trastuzumabdiagnosed with HER2 positive breast cancer
Pertuzumabdiagnosed with HER2 positive breast cancer

Purpose

This study is to see how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while receiving chemotherapy.

Detailed Description

      All the eligible patients will fast 24 hours before and 24 hours after the administration of
      chemotherapy which will consist of doxorubicin plus cyclophosphamide every 2 weeks for four
      cycles followed by paclitaxel every 2 weeks for four cycles (dose-dense AC + T) For patients
      with HER2 negative breast cancer, or for patients with HER2 positive breast cancer: docetaxel
      (T) every 3 weeks for four cycles. Trastuzumab (H) and Pertuzumab (P) will be given
      concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not
      achieve pathological complete remission (pCR), adjuvant chemotherapy with doxorubicin (A)
      plus cyclophosphamide (C) every 3 weeks for four cycles will be given, followed by
      trastuzumab every 3 weeks to complete 1 year of treatment. For patients with pCR, only
      trastuzumab every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH +
      AC).
    

Trial Arms

NameTypeDescriptionInterventions
Diagnosed with HER2 negative breast cancerActive ComparatorPatients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.
  • Doxorubicin
  • cyclophosphamide
  • paclitaxel
diagnosed with HER2 positive breast cancerActive Comparatorwill receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
  • docetaxel
  • Trastuzumab
  • Pertuzumab

Eligibility Criteria

        Inclusion Criteria:

          -  Patients ≥ 18 years of age with histologically, and radiographically confirmed
             non-metastatic breast cancer with minimal tumor size over 1 cm (≥T1c lesion) to
             receive neoadjuvant chemotherapy recommended by the treating physician

          -  For estrogen receptor (ER) strongly positive, human epithelial receptor (HER2)
             negative breast cancer, Oncotype Dx study is required. Patients with low recurrence
             score will be excluded in the study.

          -  Eastern Cooperative Oncology Group (ECOG) performance status score < 1

          -  Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5
             g/dL

          -  Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 1.5
             X ULN (≤ 3 mg/dL if clinically diagnosed with Gilbert syndrome) AST/ALT ≤ 2.5 X ULN
             (AST/ALT ≤ 5X ULN if clinically diagnosed with Gilbert syndrome)

          -  Willing to provide blood samples for correlative research purposes

          -  Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
             sterile) must be willing to use an acceptable contraceptive method (abstinence, oral
             contraceptive or double barrier method) for the duration of the study and for 30 days
             following the last dose of study drug, and must have a negative urine or serum
             pregnancy test within 2 weeks prior to beginning treatment on this trial.

        Exclusion Criteria:

          1. Uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias,
             congestive heart failure (NYHA grade 2 or more or LVEF < 40% on any prior assessment).
             Note: Assessment of LVEF is done before and after anthracycline-based or
             trastuzumab-based chemotherapy as standard of care

          2. Pregnant or lactating females

          3. Known history of diabetes mellitus. If screening fasting glucose is ≥126 mg/dL, an
             HbA1C must be < 6.5%.

          4. History of syncope with calorie restriction in the past

          5. Body mass index (BMI) < 19 kg/m2

          6. Clinical signs or symptoms of GI obstruction and/or requirement for parenteral
             hydration or nutrition

          7. Inability to complete informed consent process and adhere to the protocol treatment
             plan and follow-up requirements

          8. Concurrent severe illness such as active infection, or psychiatric illness/social
             situations that would limit safety and compliance with study requirements

          9. Any other medical comorbidity that requires daily medication(s) that may not be safely
             taken without food.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluate Pathological Complete Remission Rate at the Time of Surgery, or Partial Pathological Response Rate (Defined as Residual Invasive Disease of 1cm) at the Time of Surgery or at the Time of Biopsy Upon Completion of Planned Chemotherapy.
Time Frame:4-6 cycles (up to 12 weeks)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:The Effect of Short-term Fasting on the Toxicity of Neoadjuvant Chemotherapy in Breast Cancer Patients According to the NCI Common Toxicity Criteria (Version 4.03)
Time Frame:4-6 cycles (up to 12 weeks)
Safety Issue:
Description:
Measure:Pathological Complete Remission Rate at the Time of Surgery, or Partial Pathological Response Rate at the Time of Surgery or at the Time of Biopsy Upon Completion of Planned Chemotherapy for Triple-negative Breast Cancer
Time Frame:4-6 cycles
Safety Issue:
Description:To evaluate pathological complete remission rate (defined as disappearance of all invasive tumor in the breast; ypT0-is) at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm, ypT1a-b) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy for triple-negative breast cancer
Measure:Changes in Plasma Insulin Abnormalities After Short-term Fasting and Chemotherapy
Time Frame:4-6 cycles (up to 12 weeks)
Safety Issue:
Description:
Measure:Biomarker Changes in Breast Cancer (Biopsy or Residual Tumor) Before and After Neoadjuvant Chemotherapy
Time Frame:4-6 cycles (up to 12 weeks)
Safety Issue:
Description:
Measure:Nutritional Status Assessment With Patient Generated Subjective Global Assessment (aPG-SGA) Before and After Neoadjuvant Chemotherapy
Time Frame:4-6 cycles (up to 12 weeks)
Safety Issue:
Description:
Measure:To Investigate Changes in Glucose After Short-term Fasting and Chemotherapy
Time Frame:4-6 cycles (up to 12 weeks)
Safety Issue:
Description:
Measure:To Investigate Changes in Insulin-like Growth Factor-1 (IGF1) After Short-term Fasting and Chemotherapy
Time Frame:4-6 cycles (up to 12 weeks)
Safety Issue:
Description:
Measure:To Investigate Changes in Plasma Blood-based Tumor-related Abnormalities in DNA After Short-term Fasting and Chemotherapy
Time Frame:4-6 cycles (up to 12 weeks)
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Western Regional Medical Center

Last Updated

October 10, 2017