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  1. A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer
  2. Program for the Assessment of Clinical Cancer tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial
  3. A Randomized, Phase 3 Study of Sunitinib in Combination with Capecitabine Compared with Capecitabine in Patients with Previously Treated Breast Cancer
  4. Bone Marrow Analysis in Early-Stage Breast Cancer
  5. A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimern of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients weith Palpable and Operable Breast Cancer
  6. A Double-Blind, Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High-Risk Lymph Node Negatice Breast Cancer
  7. A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer
  8. A Multicenter, Phase III, Randomized Trial of Adjuvant Therapy for Patients with HER-2 Positive, Node-Positive, or High Risk Node-Negative breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab
  9. A Randomized, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer
  10. A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER-2 Positive Ductal Carcinoma In Situ Resected by Lumpectomy
  11. An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer

A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer

Eligibility Criteria (prot version date 03/13/07):

  1. Subject must have Stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
  2. On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
  3. Surgical treatment of the breast must have been lumpectomy.
  4. Gross disease mut be unifocal with pathologic (invasive and/or DCIS) tumor size of 3 cm or less. (subjects with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less).
  5. Subjects with invasive breast cancer are required to have axillary staging, which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for subjects with DCIS).
  6. Subject must be randomized within 42 days following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).
  7. Target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be 30% or less based on the post-operative/pre-randomization CT scan.
  8. At time of randomization, subject must have had an H & P within 4 months and a bilateral mammogram within 6 months.
  9. Not eligible if subject has more than 3 histologically positive axillary nodes.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

Program for the Assessment of Clinical Cancer tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial

Eligiblity criteria (per Protocol dated 03/18/09):

  1. Females with operable histologically confirmed adenocarcinoma of the breast who have completed primary surgical treatment.
  2. Subject must be disease-free of prior invasive malignancy for at least 5 years, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Subjects with a previous ipsilateral or contralateral invasive breast cancer, or with bilateral synchronous cancers are not eligible. Subjects with previous ipsilateral or contralateral DCIS are not eligible.
  3. Not eligible if subject has chronic obstructive pulmonary disease requiring treatment.
  4. Not eligible if subject has chronic liver disease.
  5. Not eligible if subject has previous history of cerebrovascular accident.
  6. No prior chemotherapy for this malignancy.
  7. Not eligible if subject has chronic psychiatric condition that would impair compliance with treatment regimen.
  8. Adequate organ function.
  9. Not eligible if subject has a history of congestive heart failure or other cardiac disease that would represent a contraindication to the use of an anthracycline.
  10. The tumor must be Her2/neu negative by either fluorecent in-situ hybridization (FISH) or immunohistochemistry (e.g., 0 or 1+ by DAKO Herceptest)
  11. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Randomized, Phase 3 Study of Sunitinib in Combination with Capecitabine Compared with Capecitabine in Patients with Previously Treated Breast Cancer

Eligibility Criteria (Per Protocol Amendment #9):

  1. Histologically or cytologically proven diagnosis of breast adenocarcinoma with evidence of locally advanced or metastatic disease not amenable to surgery or radiation therapy with curative intent.
  2. Measurable disease as per RECIST or bone-only disease.
  3. Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease setting.
  4. Subject will be eligible if she is a candidate for treatment with capecitabine, not contraindicated according to the local standard of care.
  5. Prior tretament with chemotherapy, as per protocol criteria.
  6. Subject will not be eligible if there is histology of inflammatory carcinoma with no other measurable disease.
  7. Subject will not be eligible if there have been at least 3 chemotherapy regimens in the advanced disease setting.
  8. Subject will not be eligible if there has been prior treatment with capecitabine or sunitinib.
  9. Subject will not be eligible if she is currently on another clinical trial.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

Bone Marrow Analysis in Early-Stage Breast Cancer

Eligibility Criteria (Per Protocol dated 01/15/07):

  1. Histologic Diagnosis of invasive adenocarcinoma of the breast diagnosed by core, incisional, or excisional biopsy.
  2. All of the following staging criteria must be met:
    • Primary tumor must be operable and staged as cT1-3 by clinical evaluation.
    • Ipsilateral nodes must be cN0-1 by clinical evaluation.
    • No evidence of metastatic disease.
  3. Subject will not be eligible if there is any history of breast malignancy, including DCIS (subjects with a history of LCIS are eligible).
  4. Subjects will not be eligible if there has been prior treatment including radiation therapy, chemotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer.
  5. Subject who will be receiving preoperative chemotherapy are not eligible.
  6. Subjects with malignancy in both breasts are excluded (this includes DCIS).
  7. Subject is ineligible if there are other non-breast malignancies, unless the subject is considered disease-free for at least 5 years before study entry, and is deemed by their physician to be at low risk for recurrence.
  8. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimern of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients weith Palpable and Operable Breast Cancer

Eligibility Criteria (Per protocol dated 09/18/2008):

  1. Females with ECOG Performance Status of 0 or 1.
  2. Breast tumor/target lesion must meet criteria for measurable disease (equal or greater than 2.0 cm), as determined by protocol guidelines.
  3. Diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
  4. The breast cancer must be determined to be HER2-positive prior to study entry. Assays performed using fluorescent in situ hybridization (FISH) require gene amplification. Assays using immunohistochemistry (IHC) require a strongly positive (3+) staining intensity score.
  5. Within 3 months prior to entry, the subject must have a baseline left ventricular ejection (LVEF) measured by MUGA scan of at least 55.
  6. Subject with a history of DCIS or synchronous DCIS of the contralateral breast regardless of therapy are eligible. Those with synchronous invasive breast cancer are NOT eligible.
  7. Subjects with a history of non-breast malignancies are eligible if they have remained disease-free for 5 years since completing their initial treatment regimen and are deemed by their physician to be at low risk for recurrence. Subjects with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  8. Subject must not have had any surgical axillary staging procedure prior to study entry. However, subjects who have had FNA of an axillary node are eligible.
  9. Subject must NOT have defenitive clinical or radiologic evidence of metastatic disease.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Double-Blind, Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High-Risk Lymph Node Negatice Breast Cancer

Eligibility Criteria (Per protocol dated 05/28/08):

  1. Histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on protocol criteria.
  2. Subject must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, breast conservation surgery and axillary dissection or breast conservation surgery and sentinel node biopsy.
  3. ECOG Performance status of 0-1.
  4. Adequate organ function within no more than 8 weeks prior to randomization, and as determined by the protocol.
  5. Margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS). Subjects with resection margins positive for lobular carcinoma in situ (LCIS) are eligible.
  6. Not eligible if subject has HER2+(3+ by IHC or FISH+) breast cancer.
  7. Not eligible if there is clinical evidence of inflammatory disease or fixed axillary nodes at diagnosis.
  8. Subject must not have had any major surgical procedure within 28 days of Day 1 study treatment.
  9. Subject must not have clinically significant cardiovascular or cerebrovascular disease.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer

Eligibility Criteria (Per Protocol dated 12/12/2007):

  1. Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent metastatic disease, and candidate for chemotherapy. Subjects with measurable and non-measurable lesion are eligible.
    Locally recurrent disease must not be amenable to resection with curative intent.
    Note: Subjects with de-novo Stage IV disease are eligible.
  2. Must be HER2-positive.
  3. Left ventricular ejection fraction (LVEF) of at least 50% at baseline (within 42 days of randomization), as determined by either ECHO or MUGA scan.
  4. ECOG Performance status of 0 or 1.
  5. Subject is not eligible if there is history of anticancer therapy for MBC.
  6. Subject not eligible if there is history of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting.
  7. Subject not eligible of there is history of systemic breast cancer treatment in the neoadjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of less than 12 months.
  8. Subject not eligible if there is history of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
  9. Subject not eligible if there is current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders, ulcers, or bone fractures).
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Multicenter, Phase III, Randomized Trial of Adjuvant Therapy for Patients with HER-2 Positive, Node-Positive, or High Risk Node-Negative breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab

Eligibility Criteria (per Protocol dated 05/06/09):

  1. ECOG Performance Status of 0 or 1.
  2. The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
  3. Subject must have undergone either a total mastectomy or breast consering surgery (lumpectomy).
  4. The interval between the last surgery fopr breast cancer (treatment or staging) and randomization must be at least 28 days, but no more than 84 days.
  5. Subject must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, the PgR analysis must also be performed.
  6. Adequate recent postoperative blood counts, as determined by the protocol.
  7. Adequate hepatic function must be met based on the results of the most recent postoperative tests, performed within 6 weeks prior to randomization.
  8. Not eligible if there is synchronous contralateral invasive breast cancer (subjects with synchronous or previous contralateral DCIS or LCIS are eligible).
  9. Not eligible if there has been previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or bevacizumab for any malignancy.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Randomized, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer

Eligibility Criteria (per protocol dated 04/22/09):

  1. ECOG Performance status of 0 or 1.
  2. Non-metastatic, operable primary invasive adenocarcinoma of the breast fulfilling the following: histologically confirmed; adequately excised (certain exceptions apply); axilla dissected (sentinel node sampling is allowed provided that axillary dissection follows confirmation of a positive sentinel node); sentinel node sampling alone is NOT acceptable after neoadjuvant therapy (in subjects receiving neoadjuvant chemotherapy, lymph node status will be considered unknown, regardless of the results of post-chemotherapy axillary dissection); Axillary node positive subject OR node negative subject with a tumor greater than or equal to 1.0 cm in greatest diameter.
  3. Known hormone receptor status (ER/PgR or ER alone)
  4. Must have received at least 4 cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen.
  5. Not eligible if there is history of any prior invasive breast carcinoma.
  6. Not eligible if there is past (less than 10 years) or current histroy of malignant neoplasms, except curatively treated basal and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
  7. Not eligible if there is any staged T4 tumor, including inflammatory breast cancer.
  8. Not eligible if there are bilateral tumors.
  9. Not eligible if there has been any prior irradiation, except internal mammary node irradiation for the present breast cancer.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER-2 Positive Ductal Carcinoma In Situ Resected by Lumpectomy

Eligibility Criteria (Per protocol dated 05/28/08):

  1. Females 18 or older, with ECOG Performance status of 0 or 1.
  2. On histologic examination, the tumor must be ductal carcinoma in situ (DCIS)- Subjects with mixed DCIS and lobular carcinoma in situ (LCIS) are also eligible.
  3. The DCIS must be HER2-positive as determined by central testing.
  4. Estrogen and/or progresterone receptor status must be determined prior to randomization (subjects with DCIS that is hormone receptor positive or negative are eligible).
  5. All DCIS must have been resected by lumpectomy.
  6. The margins of the resected speciment must be histologically free of DCIS. For subejcts in whom pathologic examination demonstrates DCIS presents at the line of resection, re-excision(s) may be performed to obtain clear margins (subjects who require mastectomy are not eligible).
  7. Not eligible if there is invasive (including microinvasion staged as T1mic) breast cancer. (However, subjects with DCIS “suspicious” for microinvasion, but not confirmed, are eligible).
  8. Not eligible if there is nodal staging of pN1 (including pN1mi)- NOTE: Axillary staging is not required.
  9. Not eligible if DCIS is present in more than one quadrant (multicentric).
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer

Eligibility Criteria (Per Protocol dated 05/05/08):

  1. Locally recurrent or metastatic breast cancer.
  2. Receipt of first systemic cytotoxic chemotherapy and/or targeted therapy among those with HER2-normal disease of first hormone therapy among those with HR-positive disease for the treatment of locally recurrent or metastatic disease, no greater than 1 month prior to enrollment.
  3. Not eligible if there is any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with the subject’s ability to provide informed consent or comply with the treatment.
  4. Not eligible if there is concurrent participation in a blinded clinical trial.
  5. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

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