A Phase 1/2 interventional study of Doxorubicin and cyclophosphamide in HER2-positive Breast Cancer, sponsored by Western Regional Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-24.
Sponsored by Western Regional Medical Center · Phase 1/2, Interventional, and Treatment
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.
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).
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 8 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Western Regional Medical Center is the lead sponsor of 23 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Doxorubicin · Drug: cyclophosphamide · Drug: 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
Drug: docetaxel · Drug: Trastuzumab · Drug: Pertuzumab
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
Also known as: (dose-dense AC + T).2
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
Also known as: (dose-dense AC + T).20
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
Also known as: (dose-dense AC + T).20
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
Also known as: (TPH + AC).21
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
Also known as: (TPH + AC).21
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
Also known as: (TPH + AC).21
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.
Time frame: 4-6 cycles (up to 12 weeks)
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)
Time frame: 4-6 cycles (up to 12 weeks)
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.
Time frame: 4-6 cycles
Insulin Abnormalities
Changes in plasma insulin abnormalities after short-term fasting and chemotherapy
Time frame: 4-6 cycles (up to 12 weeks)
Biomarker Changes Before and After Chemotherapy
Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy
Time frame: 4-6 cycles (up to 12 weeks)
Nutritional Assessment Before and After Neoadjuvant Chemotherapy
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)
Glucose After Fasting and Chemotherapy
To investigate changes in glucose after short-term fasting and chemotherapy
Time frame: 4-6 cycles (up to 12 weeks)
Changes in Insulin-like Growth Factor-1
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)
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
Time frame: 4-6 cycles (up to 12 weeks)
| Milestone | Diagnosed With HER2 Negative Breast Cancer | Diagnosed With HER2 Positive Breast Cancer |
|---|---|---|
| Started | 3 | 5 |
| Completed | 0 | 0 |
| Not completed | 3 | 5 |
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.
No measurements were reported for this outcome.
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)
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Changes in plasma insulin abnormalities after short-term fasting and chemotherapy
No measurements were reported for this outcome.
Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy
No measurements were reported for this outcome.
Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy
No measurements were reported for this outcome.
To investigate changes in glucose after short-term fasting and chemotherapy
No measurements were reported for this outcome.
To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy
No measurements were reported for this outcome.
To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy
No measurements were reported for this outcome.
Collected over NA Data was not collected. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnosed With HER2 Negative Breast Cancer | — | — | — |
| Diagnosed With HER2 Positive Breast Cancer | — | — | — |
Data not collected. PI no longer at this institution
| Age, Categorical | Diagnosed With HER2 Negative Breast Cancer | Diagnosed With HER2 Positive Breast Cancer | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Sex: Female, Male | Diagnosed With HER2 Negative Breast Cancer | Diagnosed With HER2 Positive Breast Cancer | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Region of Enrollment | Diagnosed With HER2 Negative Breast Cancer | Diagnosed With HER2 Positive Breast Cancer | Total |
|---|
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Doxorubicin · Cyclophosphamide · Paclitaxel · Docetaxel
Western Regional Medical Center