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.
Title
- Brief Title: Fasting on 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
- HER2-positive Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
Doxorubicin | (dose-dense AC + T).2 | HER2 negative breast cancer |
cyclophosphamide | (dose-dense AC + T).20 | HER2 negative breast cancer |
paclitaxel | (dose-dense AC + T).20 | HER2 negative breast cancer |
docetaxel | (TPH + AC).21 | HER2 positive breast cancer |
Trastuzumab | (TPH + AC).21 | HER2 positive breast cancer |
Pertuzumab | (TPH + AC).21 | 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
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) or 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
Name | Type | Description | Interventions |
---|
HER2 negative breast cancer | Active Comparator | Doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, 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
|
HER2 positive breast cancer | Active Comparator | Docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles. Pegfilgrastim after docetaxel. Surgery three to six weeks after completing the last docatexel. If additional chemotherapy is needed patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle then trastuzumab for 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: | Pathological Response Rate at the Time of Surgery or at the Time of Biopsy |
Time Frame: | 4-6 cycles (up to 12 weeks) |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI |
Time Frame: | 4-6 cycles (up to 12 weeks) |
Safety Issue: | |
Description: | 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) |
Measure: | Pathological Response Rate at the Time of Surgery or Time of Biopsy Upon Completion of Planned Chemotherapy |
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: | Insulin Abnormalities |
Time Frame: | 4-6 cycles (up to 12 weeks) |
Safety Issue: | |
Description: | Changes in plasma insulin abnormalities after short-term fasting and chemotherapy |
Measure: | Biomarker Changes Before and After Chemotherapy |
Time Frame: | 4-6 cycles (up to 12 weeks) |
Safety Issue: | |
Description: | Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy |
Measure: | Nutritional Assessment Before and After Neoadjuvant Chemotherapy |
Time Frame: | 4-6 cycles (up to 12 weeks) |
Safety Issue: | |
Description: | Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy |
Measure: | Glucose After Fasting and Chemotherapy |
Time Frame: | 4-6 cycles (up to 12 weeks) |
Safety Issue: | |
Description: | To investigate changes in glucose after short-term fasting and chemotherapy |
Measure: | Changes in Insulin-like Growth Factor-1 |
Time Frame: | 4-6 cycles (up to 12 weeks) |
Safety Issue: | |
Description: | To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy |
Measure: | Plasma Blood-based Tumor-related Abnormalities in DNA |
Time Frame: | 4-6 cycles (up to 12 weeks) |
Safety Issue: | |
Description: | To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Western Regional Medical Center |
Last Updated
April 24, 2018