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Fasting on Newly Diagnosed Breast Cancer (STEFNE)

Primary Purpose

HER2-positive Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Doxorubicin
cyclophosphamide
paclitaxel
docetaxel
Trastuzumab
Pertuzumab
Sponsored by
Western Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2-positive Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Western Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HER2 negative breast cancer

HER2 positive breast cancer

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Pathological Response Rate at the Time of Surgery or at the Time of Biopsy
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

Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI
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)
Pathological Response Rate at the Time of Surgery or Time of Biopsy Upon Completion of Planned Chemotherapy
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.
Insulin Abnormalities
Changes in plasma insulin abnormalities after short-term fasting and chemotherapy
Biomarker Changes Before and After Chemotherapy
Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy
Nutritional Assessment Before and After Neoadjuvant Chemotherapy
Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy
Glucose After Fasting and Chemotherapy
To investigate changes in glucose after short-term fasting and chemotherapy
Changes in Insulin-like Growth Factor-1
To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy
Plasma Blood-based Tumor-related Abnormalities in DNA
To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy

Full Information

First Posted
January 12, 2015
Last Updated
March 26, 2018
Sponsor
Western Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02379585
Brief Title
Fasting on Newly Diagnosed Breast Cancer
Acronym
STEFNE
Official Title
A Pilot Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer (STEFNE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
PI Decision
Study Start Date
January 2013 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HER2 negative breast cancer
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HER2 positive breast cancer
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
(dose-dense AC + T).2
Intervention Description
doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
(dose-dense AC + T).20
Intervention Description
doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
(dose-dense AC + T).20
Intervention Description
For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
(TPH + AC).21
Intervention Description
For patients with HER2 positive breast cancer: docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
(TPH + AC).21
Intervention Description
docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
(TPH + AC).21
Intervention Description
docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21
Primary Outcome Measure Information:
Title
Pathological Response Rate at the Time of Surgery or at the Time of Biopsy
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.
Time Frame
4-6 cycles (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI
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)
Time Frame
4-6 cycles (up to 12 weeks)
Title
Pathological Response Rate at the Time of Surgery or Time of Biopsy Upon Completion of Planned Chemotherapy
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.
Time Frame
4-6 cycles
Title
Insulin Abnormalities
Description
Changes in plasma insulin abnormalities after short-term fasting and chemotherapy
Time Frame
4-6 cycles (up to 12 weeks)
Title
Biomarker Changes Before and After Chemotherapy
Description
Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy
Time Frame
4-6 cycles (up to 12 weeks)
Title
Nutritional Assessment Before and After Neoadjuvant Chemotherapy
Description
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)
Title
Glucose After Fasting and Chemotherapy
Description
To investigate changes in glucose after short-term fasting and chemotherapy
Time Frame
4-6 cycles (up to 12 weeks)
Title
Changes in Insulin-like Growth Factor-1
Description
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)
Title
Plasma Blood-based Tumor-related Abnormalities in DNA
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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 Pregnant or lactating females Known history of diabetes mellitus. If screening fasting glucose is ≥126 mg/dL, an HbA1C must be < 6.5%. History of syncope with calorie restriction in the past Body mass index (BMI) < 19 kg/m2 Clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements Any other medical comorbidity that requires daily medication(s) that may not be safely taken without food.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Waypa, FNP
Organizational Affiliation
Research Director
Official's Role
Study Director
Facility Information:
Facility Name
Western Regional Medical Center
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fasting on Newly Diagnosed Breast Cancer

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