Current partner codePEPTIDESDE

Fasting on Newly Diagnosed Breast Cancer

Status

Terminated

Phase

Phase 1 / Phase 2

Enrollment

8

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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).

Interventions

Treatment arms and agents.

DRUG

Doxorubicin

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

DRUG

cyclophosphamide

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

DRUG

paclitaxel

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

DRUG

docetaxel

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

DRUG

Trastuzumab

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

DRUG

Pertuzumab

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

Timeline

From registration to results.

  1. First posted

    Mar 5, 2015

  2. Study start

    Jan 2013

  3. Primary completion

    Aug 2015

  4. Study completion

    Aug 2015

  5. Results posted

    Nov 8, 2017

  6. Registry updated

    Apr 24, 2018

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 4-6 cycles (up to 12 weeks)

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 outcomes

Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI

Time frame · 4-6 cycles (up to 12 weeks)

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

Time frame · 4-6 cycles

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

Time frame · 4-6 cycles (up to 12 weeks)

Changes in plasma insulin abnormalities after short-term fasting and chemotherapy

Biomarker Changes Before and After Chemotherapy

Time frame · 4-6 cycles (up to 12 weeks)

Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy

Nutritional Assessment Before and After Neoadjuvant Chemotherapy

Time frame · 4-6 cycles (up to 12 weeks)

Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy

Glucose After Fasting and Chemotherapy

Time frame · 4-6 cycles (up to 12 weeks)

To investigate changes in glucose after short-term fasting and chemotherapy

Changes in Insulin-like Growth Factor-1

Time frame · 4-6 cycles (up to 12 weeks)

To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy

Plasma Blood-based Tumor-related Abnormalities in DNA

Time frame · 4-6 cycles (up to 12 weeks)

To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Western Regional Medical Center

Goodyear, Arizona, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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