Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Lisa R David, MD

The purpose of this study is to provide the physicians with quality long term follow up data on subjects from the Breast Cancer Clinic and the Plastic Surgery Clinic who have been newly diagnosed with breast cancer and will receive treatment for the cancer at this facility. Over the last two decades many studies have been done concerning the quality of life after a mastectomy and/or reconstruction process. The majority of these studies only run for one year post reconstruction, some however, do include a two year follow up. The investigators are proposing a 5 year long term follow up study on subjects who will be diagnosed and treated here at the Breast Cancer Clinic and the Plastic Surgery Clinic. The investigators first questionnaire will be given prior to any treatment for breast cancer, giving us a baseline for the subject's current quality of life. At each successive year, the subject will be given another questionnaire with regards to their progression through the reconstructive process. At the end of 5 years, the subject will complete a final questionnaire. These questionnaires will deal with many areas of daily life functions; activities of daily living, anxiety, depression, social interactions, personal and sexual relationships.

Upon informed consent of subject, a baseline questionnaire will be completed by the subject. At years 1, 2, 3, and 4 follow up questionnaires will be sent for completion to the subject. At year 5 a final questionnaire will be sent to the subject for completion.After all subjects have completed the study, data will be sent to the Department of Biostatics for analysis.

A 5 Year Follow-up on Newly Diagnosed Breast Cancer Patients

A Prospective Study on Newly Diagnosed Breast Cancer Patients: A 5 Year Follow Up on Quality of Life

Wake Forest University

Symptoms and General Pathology

Recurrence

All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy

All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy ± hormonal therapy

All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only.

To identify a panel of circulating miRNA markers which could help identify those breast cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy, and indeed serve as an overall prognostic factor and stratify patients into risk categories which would further guide their management. Similarly, the investigators aim to identify a panel of circulating miRNA markers which could monitor patient's response to chemotherapy and hormonal therapies. Ideally a suitable panel of markers would show significant changes in expression level in good-responders whilst little or no change would be observed in miRNA expression in non-responders.

Primary Objectives:

1. To identify a panel of miRNAs, detectable in the circulation, which are altered in breast cancer patients
2. To identify specific combinations of miRNAs ('signatures') which associate with breast cancer intrinsic subtypes, and thereby could aid in prognostication and treatment planning on an individual patient basis.

Secondary Objective:

1. To determine if systemic miRNA analysis can be used as a biomarker for monitoring response to chemotherapy, in the neoadjuvant setting and in patients who present with breast cancer recurrence and are treated with upfront chemotherapy and/or hormonal therapy.

   This is a prospective cohort studies, involving three study cohorts:

   Cohort 1: All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy.

   Cohort 2: All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy +/- hormonal therapy.

   Cohort 3: All breast cancer patients who present with metastatic disease who are commencing hormonal therapy only.

   Blood Sample

   Blood Sampling - Cohort 1:

   - Blood sample 1: at presentation before commencing neoadjuvant treatment.

   - Blood sample 2: midway through their chemotherapy treatment (after 2nd cycle if they are enrolled in a 4 cycle regimen, or after 4th cycle if they are prescribed an 8 week regimen).

   - Blood sample 3: post-chemotherapy (before surgery as applicable).

   - Blood sample 4: 2 to 4 weeks after surgery, or 2 to 4 weeks post 3rd blood sampling if patients do not undergo surgery.

   - Blood sample 5: once during follow-up of 12 to 18 months after surgery or 12 to 18 months post 3rd blood sampling if patients do not undergo surgery.

   Blood Sampling - Cohort 2:

   - Pre-treatment blood sample: at presentation before commencing treatment.

   - On study blood samples: taken at monthly (± 1 week) intervals for a period of 6 months from date of pre-treatment blood sample, despite whether the patient is on treatment or completed treatment.

   On study blood sample 1: 1 month (± 1 week) from date of pre-treatment blood sample

   On study blood sample 2: 2 months (± 1 week) from date of pre- treatment blood sample

   On study blood sample 3: 3 months (± 1 week) from date of pre-treatment blood sample

   On study blood sample 4: 4 months (± 1 week) from date of pre-treatment blood sample

   On study blood sample 5: 5 months (± 1 week) from date of pre-treatment blood sample

   On study blood sample 6: 6 months (± 1 week) from date of pre-treatment blood sample

   - End of study blood sample: once during follow-up of 12 to 18 months from date of pre-treatment blood sample or at the time of disease progression.

   Blood Sampling - Cohort 3:

   - Pre-treatment blood sample: at presentation before commencing treatment.

   - On study blood samples: taken at the following time points despite whether the patient is on treatment or completed treatment.

   On study blood sample 1: 3 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 2: 6 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 3: 12 months (± 2 weeks) from date of pre-treatment blood sample

   - End of study blood sample: 18 months (± 2 weeks) from date of pre-treatment blood sample or at the time of disease progression.

   Blood samples will be processed for miRNA analysis, which involves:

1. Lysis using Trizol 2. RNA isolation 3. Assessing concentration and integrity of RNA using Nanodrop spectrophotometry 4. cDNA synthesis (using miRNA specific stem loop primers) 5. PCR amplification and relative quantification (using miRNA specific probes)

Circulating miRNAs.

Novel Breast Cancer Biomarkers and Their Use for Guiding and Monitoring Response to Chemotherapy

For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses.

For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1." For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses.

For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1."

Standard bio markers of response include serum CEA and Ca15-3 levels

Other existing clinicopathological parameters include: ER, PR and HER2 status, stage of disease,histological grade and size of the tumour, and the Nottingham Prognostic Index.

Cancer Trials Ireland

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Sunitinib

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

The study will be conducted in 3 sequential treatment segments.

sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks.

sunitinib alone

sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.

sunitinib plus paclitaxel

doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.

doxorubicin and cyclophosphamide

Kathy Miller, MD

The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading to other parts of the body. This study is being done to test the impact of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition of sunitinib will make the treatment more effective, but we don't know if this is true.

Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer

An Exploratory Study of the Biological and Clinical Activity of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer

Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.

Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value.

This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib.

Pfizer

Indiana University

Professor of Medicine

Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation.

Single Agent Sunitinib

4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.

Paclitaxel/Sunitinib

4 cycles (8 weeks) of neoadjuvant treatment with AC.

AC Dosing

These patients are for the patients who were into the trial.

Overall Study

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Kathy Miller

From Taghian et al., we used a mean IFP of 6.5 at baseline and a standard deviation of 6.1. We would like to detect a 50% reduction of IFP (to 3.25 mmHg) with sunitinib monotherapy, so the effect size would be 3.25/6.1=0.53. A two-sided paired t-test has 80% power to detect an effect size of .53 and level of significance .05 when the sample size is 30 patients.

Patients who completed the Sunitinib monotherapy segment

Sunitinib Monotherapy

All patients that had both measures at baseline and endpoint in the sunitinib monotherapy segment

Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy

Patients who finished the paclitaxel plus sunitinib segment

Paclitaxel Plus Sunitinib

All patients in the paclitaxel plus sunitinib segment

Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy

Patients who finished the AC dosing segment

Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer

Patients who were in the paclitaxel plus sunitinib segment

All patients who were on paclitaxel plus sunitinib.

To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy

This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response.

Segment Information

Single Agent Sunitinib (Cycle 1)

Paclitaxel/Sunitinib (Cycles 2-5)

AC (Cycles 6-9)

Fatigue

Breast cancer patients treated by adjuvant chemotherapy after their surgery. The time points of data collection are before the start of the first, second, fourth and sixth cycle of chemotherapy. If patients are treated by radiotherapy after the chemotherapy, there are 2 measurements points pre- and post radiotherapy.The others measurement points are at 12,18 and 24 months after surgery.

Breast cancer patients no treated by adjuvant chemotherapy after their surgery. For patients treated by radiotherapy after surgery, there are 2 measurement points pre- and post radiotherapy. The others measurement points are at 4,6,7,8,12,18 and 24 months after surgery.

Rotonda Christine, PhD student

Conroy Thierry, PU-PH

Bonnetain Franck

Velten Michel

Guillemin Francis, PU-PH

The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored. A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to meet the study aims.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A 5 Year Follow-up on Newly Diagnosed Breast Cancer Patients	NCT01176838	Newly Diagnosed...		18 Years -	Wake Forest University Health Sciences
Circulating miRNAs.	NCT01722851	Breast Cancer Newly Diagnosed... Recurrent Breas...		18 Years -	Cancer Trials Ireland
A 5 Year Follow-up on Newly Diagnosed Breast Cancer Patients	NCT01176838	Newly Diagnosed...		18 Years -	Wake Forest University Health Sciences
A 5 Year Follow-up on Newly Diagnosed Breast Cancer Patients	NCT01176838	Newly Diagnosed...		18 Years -	Wake Forest University Health Sciences
Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer	NCT00656669	Breast Cancer	sunitinib alone sunitinib plus ... doxorubicin and...	18 Years -	Indiana University
Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer	NCT00656669	Breast Cancer	sunitinib alone sunitinib plus ... doxorubicin and...	18 Years -	Indiana University
Factors Correlated With Fatigue in Breast Cancer	NCT01064427	Newly Diagnosed... Surgery Program...		18 Years - 80 Years	Central Hospital, Nancy, France

Spots Global Cancer Trial Database for newly diagnosed breast cancer