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Breast Cancer Clinical Trial Information

The breast cancer protocol information is intended for use by a healthcare professional. If you have questions about a referral, please contact your provider.

Select Study Type

If after reviewing your clinical information, you are found to be a candidate for a clinical trial at the Arizona Cancer Center, an appointment can be made for your evaluation.

If you live in one of the communities that is a site for the Arizona Telemedicine Program, this initial appointment may be made via teleconferencing. You and your provider would be able to interact directly with a medical oncologist at the Arizona Cancer Center and discuss your condition.


Phase I Studies

 
Eligibility: Thank you for your interest in Phase I Studies. Phase I studies are the first step in the clinical trial process. People who are eligible for phase I studies are not eligible for standard therapy. If your provider feels you are in this category please request specific information by clicking the link below.
Referral Form
For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 
An Open Label, Dose Escalation Study to Determine the Maximum Tolerated Dose and to Evaluate the Safety Profile of CC-5513 with Weekly Docetaxel (Taxotere ®)
Eligibility: Subjects with Advanced Solid Tumors
Treatment: Docetaxel is a standard therapy for many tumors and given every week in the vein. CC-5013 is an experimental therapy given every day by mouth for 21 days in a row along with the docetaxel. The study drug, CC-5013, will be supplied free of charge by Celgene corporation.
Referral Form
For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 


Prevention/Early Detection

Study of tamoxifen and raloxifene (STAR) for the Prevention of Breast Cancer

HSC 99-93

Eligibility: Patient must be at high risk for developing breast cancer and must not have had prior tamoxifen, raloxifene or other selective estrogen receptor modulator treatment.
Treatment: I: Tamoxifen      II: Raloxifene
Referral Form
For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 


Treatment

Primary

C49907: A Randomized Trial of Adjuvant Chemotherapy with Standard Regimens, Cyclophosphamide, Methotrexate, and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide (AC), Versus Capecitabine in Women 65 years and Older with Node Positive or High-Risk Node Negative Breast Cancer
Eligibility: Must be 65 years or older with early stage tumor removed by modified radical mastectomy or a lumpectomy.  Patients must have had either an axillary node dissection or sentinel lymph node biopsy before beginning this treatment.

Less than 84 days from mastectomy or within 84 days of axillary dissection if patient's most extensive breast surgery was a breast sparing procedure.

Treatment: Patient will be randomized to one of these two arms:

Arm A: Cyclophosphamide, Methotrexate, and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide (AC)

Arm B: Capecitabine

Referral Form

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 
CALGB/SWOG 40101: Cyclophosphamide and Doxorubicin (CA) (4 versus 6 cycles) versus Paclitaxel (12 weeks versus 18 weeks) as Adjuvant Therapy for Women with Node-Negative Breast Cancer: A 2x2 Factorial Phase III Randomized Study.

Eligibility: Histologically confirmed adenocarcinoma of the female breast and negative lymph nodes determined by either an axillary node dissection or a positive sentinel node finding by H&E, with clear margins.

Less than 84 days from mastectomy or from axillary dissection or sentinel node detection if the patient’s most extensive breast surgery was a breast sparing procedure. 

Treatment: Patients will be randomized to one of three arms:

Arm I: AC q 2 weeks for 4 cycles (60/600)

Arm II: AC q 2 weeks for 6 cycles (60/600)

Arm III: Paclitaxel q 2 weeks for 12 weeks (80)

Arm IV: Paclitaxel q 2 weeks for 18 weeks (80)

Referral Form

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 

B-35: A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy with Radiation Therapy.

Eligibility:  Histologic examination the tumor must be ductal carcinoma in situ (DCIS) and be ER/PR positive as confirmed by IHC. Margins must be clear and any node dissection (if done) must be pathologically negative.

Less than 84 days from lumpectomy or re-excision of lumpectomy margins to the randomization of this trial.

Treatment: Patients will be randomized to two treatment arms:

Group 1: Tamoxifen (20mg) and placebo (daily) x 5 years + Breast Radiation Therapy

Group 2: Anastrozole (1mg) and placebo (daily) x 5 years + Breast Radiation Therapy

Referral Form

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 

High Risk

Study of tamoxifen and raloxifene (STAR) for the Prevention of Breast Cancer

HSC 99-93

Eligibility: Patient must be at high risk for developing breast cancer and must not have had prior tamoxifen, raloxifene or other selective estrogen receptor modulator treatment.
Treatment: I: Tamoxifen      II: Raloxifene
Referral Form
For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 

Node-Positive or High-Risk Node Negative Dose Dense

SWOG 0221    

Phase III Trial of Continuous Schedule AC + G vs. Q 2 week Schedule AC followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post Operative Adjuvant Therapy in Node-Positive or High Risk Node Negative Breast

Cancer

Eligibility: High Risk: Histologically confirmed Diagnosis of operable Stage I, II or III invasive breast carcinoma with known estrogen and progesterone receptor status.

Tumor ~ 2 cm &/or one or more axillary or intramammary nodes involved.

Less than 84 days from final surgical procedure.

Treatment: Arm I: AC + PEG-G q 2 weeks x 6 cycles; T + PEG-G q 2 weeks x 6 cycles Arm II: AC + G x 15 weeks; T + PEG-G q 2 weeks x 6 cycles

Arm III: AC + PEG-G q 2 weeks x 6 cycles; weekly T x 12 weeks

Arm IV: AC + G x 15 weeks; weekly T x 12 weeks

Referral Form

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 

Better Than Ever Study for Women at High Risk for Breast Cancer

Eligibility:  Twenty women who are at high risk of developing breast cancer based on the Gail model, women with a BRCA mutation or women with a previously diagnosed breast cancer will be enrolled into the study. High risk women are evaluated through the High Risk Breast Cancer Clinic. Evaluation will include a complete clinical history, physical examination and a screening mammogram, ultrasound or MRL.

High risk women on the basis of at least one of the following:

  • Five year Gail score of at least 1.7%

  • History of DCIS or LCIS (path report required)

  • BRCA 1/BRCA2 positive (without mastectomy or oophorectomy)

  • One or more first degree relatives with history of breast cancer

  • Personal history of breast cancer if one breast is untreatedlintact for ductoscopy

  • Ability to produce Nipple aspirate fluid (NAF) spontaneously or elicited with massage and manual aspirator

Treatment: Subjects will be pre-selected based on successful identification of NAF secreting ducts. Suction aspiration will be applied to identify the secreting ducts. If NAF is found, patients will be scheduled for breast endoscopy. Breast endoscopies are performed in the AZCC clinics initially and repeated at 6 months. NAF, lavage fluid, and ductoscopic biopsy (if obtained) are collected and processed for pathology, karyometry, and microarray methylation analysis.

Referral Form

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 

Metastatic

 

Phase II Trial of Imatinib Mesylate (Gleevec)  in Combination with Capecitabine (Xeloda) in Metastatic Breast Cancer

SWOG 0338

Temporary Closure

Eligibility: Patients must have histologically or cytologically Stage IV adenocarcinoma of the breast.

Patients must have progressed on at least one but no more than two prior chemotherapy regimens for metastatic disease.

Patients must have measurable disease.

Treatment: Gleevec 400mg* p.o. (daily) + Capecitabine 1,OOOmg/m2 p.o. bid (days 1-14) * if patients tolerates the starting dose of Gleevec (400mg) it will be increased to 600mg/day

Referral Form

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 

Side Effect Management

Massage Treatment in Breast Cancer-Related Lymphedema

Eligibility: Patients with mild breast cancer-related lymphedema would potentially be eligible for this study.

Treatment: Patients will be randomly assigned to either massage alone or massage with bandaging treatment. Participant’s arms will be measured by study personnel and participants will complete a short questionnaire at the beginning of the study, at the end of a two week treatment period (10 sessions) and at a six-month follow up visit. 

Referral Form

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals and patients about the breast cancer-related lympheclinical trial only.  Thank you.

 

Green Tea Intervention for Weight Gain Prevention among Women with Breast Cancer

Eligibility: postmenopausal, Stage I, II, or IIIa invasive breast cancer, has completed chemotherapy in past 1 - 4 weeks and gained> 2 kg during treatment.

No prior tamoxifen treatment, no current dietary supplements with tea or tea extracts. Not on weight loss medications or in weight loss program.

Treatment: Patients will be randomly assigned to either Green Tea or Placebo Tea for 12 months. Body measurements, resting metabolic rate, blood and urine samples, and cognitive tests will be completed at baseline, 6 months and 12 months. Food, tea, exercise, demographic, and quality of life questionnaires will also be completed.

Referral Form

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

 

SHINE CARES Chemotherapy and Radiation Effects

Eligibility: SHINE CARES is currently recruiting women between the ages of and 75 who have been diagnosed with Stage I, Stage 2, or Stage 3 breast cancer two or more years ago, and have received local therapy and/or chemotherapy.

Treatment: Study participants will answer questions about their breast cancer and medical history; complete questionnaires about coping, personality, mood, and memory; have an MRI scan (a safe way to take pictures of the brain and its structures); and complete an assessment of memory and other skills.

Referral Form

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

NCI Sponsored Trials

We Need Your Help!

The National Cancer Institute (NCI) is developing new education materials to address concerns that people with cancer and their families face throughout the course of the disease.  We need to know what you believe is important to include in these materials.  We are looking for:

  • Patients:  Who have recurrent or Stage III or Stage IV cancer
  • Current informal caregivers:  Family or friends who are currently providing care for someone in treatment for cancer
  • Bereaved informal caregivers:  Family members or friends who have provided care at end of life for someone who died from cancer within the last 2 years
  • Physicians:  Who work with people with advanced cancer.

We will be conducting individual telephone interviews with patients and telephone focus group discussions with informal caregivers and health professionals to learn about your experiences with cancer.  Payment will be provided to all participants.

Please call us toll-free at:

1-888-249-0029

We will ask a few questions to see if you qualify to participate.  If you qualify, you will be contacted at a later date for scheduling.

 

We Need Your Help!

The National Cancer Institute (NCI) is developing new education materials in Spanish to address concerns that people with cancer and their families face throughout the course of the disease.  We need to know what you believe is important to include in these materials.  We are looking for:

  • Family or friends who are currently providing care for someone in treatment for cancer

  • Family members or friends who have provided care at end of life for someone who died from cancer within the last 2 years

 

We will be conducting telephone focus group discussions in Spanish to learn about your experiences with cancer.  Payment will be provided to all participants.

Please call us toll-free at:

1-888-249-0029

We will ask a few questions to see if you qualify to participate. If you qualify, you will be contacted at a later date for scheduling.

 

 ¡Necesitamos su ayuda!

El Instituto Nacional del Cáncer (National Cancer Institute o NCI) está elaborando unos nuevos materiales en español para hacer frente a las preocupaciones que tienen las personas con cáncer y sus familias. Queremos saber su opinión acerca de lo que usted considera que sea importante incluir en estos materiales. Buscamos:

  • Familiares o amigos quienes actualmente están proporcionando cuidados a alguien que está recibiendo tratamiento para el cáncer

  • Familiares o amigos quienes hayan proporcionado cuidados de hospicio a alguien con cáncer que murió en los últimos dos años

 Para enterarnos de sus experiencias con el cáncer, vamos a llevar a cabo algunos grupos de enfoque en forma de conversaciones por teléfono. Todos los participantes recibirán un pago.

Por favor, llámenos gratis al:

1-888-249-0029

 Le haremos algunas preguntas para verificar que usted cumpla con los requisitos para participar. Si usted califica, se le contactará en una fecha posterior para programar una cita.

 

Susan G. Komen Sponsored Trials

Study to Examine Memory Problems in Breast Cancer Survivors

Breast cancer is the second most common cancer in women. Fortunately, the likelihood of survival has dramatically increased in recent years, but many women experience unwanted side-effects from breast cancer treatments. Breast cancer survivors who have been treated with chemotherapy complain of changes in memory, attention, and other cognitive functions.

Eligibility: SHINE CARES is currently recruiting women between the ages of 20 and 75 who have been diagnosed with Stage 1, Stage 2, or Stage 3 breast cancer two or more years ago, and have received local therapy and/or chemotherapy.

Procedures: Study participants will answer questions about their breast cancer and medical history; complete questionnaires about coping, personality, mood, and memory; have an MRI scan (a safe way to take pictures of the brain and its structures); and complete an assessment of memory and other skills.

For more information, please click on Protocol Questions

Note: This email contact is for specific questions from healthcare professionals about breast cancer clinical trials only.  If you are a patient seeking advice on a health matter, please contact your health care provider directly.  Thank you.

Copyright 2000
Arizona Board of Regents

revised June 22, 2005