Breast Cancer Treatment Trials

Phase II Study of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Neoadjuvant Chemotherapy in Women With Stage II-IIIB Node-Positive Breast Cancer (ACOSOG Z1071)

Purpose

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.

Eligibility

Eligibility criteria include the following:

• At least 18 years old
• Has finished chemotherapy or plans to begin chemotherapy
• No previous surgery to remove or biopsy axillary lymph nodes

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

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Phase III Randomized Study of Adjuvant Therapy Comprising Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With Versus Without Bevacizumab in Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer (E5103)

Purpose

Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether doxorubicin, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab in treating breast cancer.

This randomized phase III trial is studying doxorubicin, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with lymph node-positive or high-risk, lymph node-negative breast cancer.

Eligibility

Eligibility criteria include the following:

• At least 18 years old
• Has undergone surgery (total mastectomy or lumpectomy) with either axillary dissection or sentinel node biopsy within the past 4 to 12 weeks
• No HER2/neu positive breast cancer or inflammatory breast cancer
• More than four weeks since surgery
• No previous chemotherapy or hormone therapy (other than tamoxifen or raloxifene for breast cancer prevention) for this cancer

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment Intervention

Patients will be randomly assigned (have an equal chance of being placed) to one of three treatment groups.

• Patients in group one will receive infusions of doxorubicin and cyclophosphamide and a 30- to 90-minute infusion of a placebo once in week 1. Treatment may repeat every 2 or 3 weeks for up to four courses. Patients will then receive a 1-hour infusion of paclitaxel once in weeks 1-3 and a 30- to 90-minute infusion of a placebo once in week 1. Treatment with paclitaxel and placebo may repeat every 3 weeks for up to four courses.
• Patients in group two will receive infusions of doxorubicin and cyclophosphamide and a 30- to 90-minute infusion of bevacizumab once in week 1. Treatment may repeat every 2 or 3 weeks for up to four courses. Patients will then receive a 1-hour infusion of paclitaxel once in weeks 1-3 and a 30- to 90-minute infusion of bevacizumab once in week 1. Treatment with paclitaxel and bevacizumab may repeat every 3 weeks for up to four courses.
• Patients in group three will receive infusions of doxorubicin and cyclophosphamide and a 30- to 90-minute infusion of bevacizumab once in week 1. Treatment may repeat every 2 or 3 weeks for up to four courses. Patients will then receive a 1-hour infusion of paclitaxel once in weeks 1-3 and a 30- to 90-minute infusion of a bevacizumab once in week 1. Treatment with paclitaxel and bevacizumab may repeat every 3 weeks for up to four courses. Patients will then receive a 30- to 90-minute infusion of bevacizumab every 3 weeks for up to 10 courses.

After finishing treatment, patients will be evaluated periodically for up to 15 years.

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A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab with a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients with Palpable and Operable Breast Cancer (Z1041)

Purpose

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known which combination chemotherapy regimen given together with trastuzumab is more effective in treating breast cancer.

This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be removed by surgery.

Eligibility

Eligibility criteria include the following:

• At least 18 years old
• Cancer was diagnosed by core needle biopsy
• Measurable disease
• HER2-positive cancer
• No metastatic cancer

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment Intervention

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

• Patients in group one will receive infusions of fluorouracil, epirubicin, and cyclophosphamide on day one. Treatment may repeat every three weeks for four courses. Beginning three weeks later, they will receive infusions of paclitaxel and trastuzumab once-a-week for 12 weeks. Within four weeks after finishing all chemotherapy, patients will undergo surgery to remove the tumor. Within three to four weeks after the last dose of trastuzumab, patients will receive an infusion of trastuzumab every three weeks for up to one year.
• Patients in group two will receive an infusion of paclitaxel once-a-week for 12 weeks and an infusion of trastuzumab once-a-week for 13 weeks. Beginning two weeks after finishing paclitaxel, they will receive infusions of fluorouracil, epirubicin, and cyclophosphamide every three weeks for four courses. Patients will also receive an infusion of trastuzumab once-a-week for 12 more weeks. Within four weeks after finishing all chemotherapy, they will under surgery. Beginning three to four weeks after the last dose of trastuzumab, patients will receive an infusion of trastuzumab every three weeks for up to one year.

After finishing treatment, patients will be evaluated every three months for two years and every six months for three years.

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Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: a Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer (CALGB 40302)

Purpose

Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for their growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer.

This randomized phase III trial is studying fulvestrant alone to see how well it works compared to fulvestrant and lapatinib in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive and expresses HER2.

Eligibility

Eligibility criteria include the following:

• At least 18 years old
• Disease that can be measured on an X-ray or scan
• Received one or two previous hormone therapies
• Estrogen receptor-positive and/or progesterone receptor-positive
• At least two weeks since chemotherapy
• No previous fulvestrant, gefitinib, erlotinib, lapatinib, or cetuximab

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment Intervention

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

• Patients in group one will receive lapatinib by mouth once-a-day. They will also receive an injection of fulvestrant in weeks one and three of course one and in week one of all other courses.
• Patients in group two will receive a placebo by mouth once-a-day. They will also receive an injection of fulvestrant in weeks one and three of course one and in week one of all other courses.

Treatment in both groups may repeat every four weeks for as long as benefit is shown.

Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated every six months for two years and once-a-year for three years.

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Phase III randomized study of adjuvant whole breast versus partial breast irradiation in women with ductal carcinoma in situ or stage I or II breast cancer (RTOG 0413)

Purpose

Radiation therapy uses high-energy X-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer.

This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.

Eligibility

Eligibility criteria include the following:

• At least 18 years old
• Has undergone surgery to remove the tumor
• No Paget's disease of the nipple
• Any estrogen receptor or progesterone receptor status
• No previous biological therapy, chemotherapy, or radiation therapy for this
  cancer
• No previous radiation therapy to the breast or chest

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment Intervention

Patients will be randomly assigned (have an equal chance of being placed in one of two treatment groups).

• Patients in group one will receive whole breast radiation therapy once-a-day five days-a-week for five to seven weeks.
• Patients in group two will receive partial breast radiation therapy twice-a-day on five days over a period of five to ten days.

In both groups, patients may receive chemotherapy before or after radiation therapy. Some patients may also receive hormone therapy for at least five years.

Patients will be evaluated at one month, every six months for five years and once-a-year thereafter.

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Phase III randomized study of anastrozole with or without fulvestrant as first-line therapy in postmenopausal eomen with metastatic breast cancer (S0226)

Purpose

Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the uptake of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer.

Randomized phase III trial to compare the effectiveness of anastrozole with or without fulvestrant as first-line therapy in treating postmenopausal women who have metastatic breast cancer.

Eligibility

Eligibility criteria include the following:

• No spread of cancer to brain or spinal cord
• More than one year since chemotherapy
• No previous anastrozole, letrozole, exemestane or fulvestrant

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment Intervention

Patients will be randomly assigned to one of two groups.

• Patients in group one will receive anastrozole by mouth once-a-day.
• Patients in group two will receive anastrozole by mouth once-a-day and an injection of fulvestrant every four weeks.

Treatment in both groups may continue for as long as benefit is shown. Patients will be evaluated every six months for two years and once-a-year for three years.

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Phase III Randomized Study of Neoadjuvant Therapy Comprising Exemestane Versus Letrozole Versus Anastrozole in Postmenopausal Women With Estrogen Receptor Positive Stage II or III Breast Cancer (ACOSOG Z1031)

Purpose

Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer.

This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer.

Eligibility

Eligibility criteria include the following:

• Measurable disease
• No inflammatory breast cancer
• Estrogen receptor positive tumor
• No previous radiation therapy, hormone therapy or chemotherapy for breast cancer

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment Intervention

Patients will be randomly assigned (have an equal chance of being placed) to one of three treatment groups.

• Patients in group one will receive exemestane by mouth once a day for 16 to18 weeks.
• Patients in group two will receive letrozole by mouth once a day for 16 to18 weeks.
• Patients in group three will receive anastrozole by mouth once a day for 16 to18 weeks.

All patients will then undergo surgery to remove the tumor or the whole breast.

After finishing treatment, patients will be evaluated periodically for up to ten years.

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Hormone therapy with or without combination chemotherapy in treating women who have undergone surgery for node-negative breast cancer (The TAILORx Trial) (PACCT-1)

Purpose

Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

This randomized phase III trial is trying to find out the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25.

Eligibility

Eligibility criteria include the following:

• 18 to 75 years old
• Estrogen receptor (ER)-positive and/or progesterone receptor (PR) - positive tumor
• HER2/neu negative tumor
• Has undergone surgery to remove the tumor within the past three months
• No previous chemotherapy or radiation therapy for this cancer

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment Intervention

After surgery, patients will be assigned to one of three treatment groups based on their Oncotype DX recurrence scores.

• Group one (Oncotype DX recurrence score < 11): Patients in this group will receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane by mouth for up to five years. Some patients will then continue to receive hormone therapy for an additional five years.
• Group two (Oncotype DX recurrence score 11-25): Patients in this group will be randomly assigned (have an equal chance of being placed) to receive either hormone therapy alone or combination chemotherapy and hormone therapy. The patients who receive combination chemotherapy will start receiving hormone therapy no more than four weeks after finishing combination chemotherapy. The same hormone therapies used in group one will be used. All patients will receive hormone therapy by mouth for up to five or ten years as in group one.
• Group three (Oncotype DX recurrence score > 25): Patients in this group will receive combination chemotherapy followed by hormone therapy similar to the patients in group two who are assigned to receive both types of treatment.

All patients who had breast-conserving surgery will also undergo radiation therapy. After finishing treatment, patients will be evaluated periodically for up to 20 years.

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Randomized Phase III trial of neoadjuvant therapy in patients with palpable and operable breast cancer evaluating the effect on pathologic complete response (pCR) by adding capecitabine or gemcitabine to docetaxel when administered before AC (Doxorubicin & Cyclophosphamide) with or without Bevacizumab and Correlative Science Studies attempting to identify predictors of high likelihood for pCR with each of the regimens (CTSU B-40)

Purpose

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer.

This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I, stage II, or stage IIIA breast cancer that can be removed by surgery.

Eligibility

Eligibility criteria include the following:

• At least 18 years old
• HER2-negative disease
• No previous excisional biopsy or incisional biopsy for primary breast tumor
• No breast cancer in both breasts
• No previous breast cancer or ductal carcinoma in situ
• No cancer that has spread
• No previous radiation therapy, chemotherapy, or biological therapy for this breast cancer
• No previous capecitabine, fluorouracil, gemcitabine, or bevacizumab for any cancer
• More than four weeks since surgery or open biopsy

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment Intervention

Patients will be randomly assigned (have an equal chance of being placed) to one of six treatment groups.

• Patients in group one will receive a one-hour infusion of docetaxel. Treatment may repeat every three weeks for up to four courses. They will then receive infusions of doxorubicin and cyclophosphamide. Treatment may repeat every three weeks for up to four courses. After finishing chemotherapy, patients will undergo lumpectomy or mastectomy.
• Patients in group two will receive a 30- to 90-minute infusion of bevacizumab and a one-hour infusion of docetaxel. Treatment may repeat every three weeks for up to four courses. They will then receive infusions of doxorubicin and cyclophosphamide. Treatment may repeat every three weeks for up to four courses. During the first two courses of doxorubicin and cyclophosphamide, patients will also receive an infusion of bevacizumab. After finishing chemotherapy and bevacizumab, patients will undergo lumpectomy or mastectomy. Beginning at least four to six weeks after surgery, patients will receive an infusion of bevacizumab. Treatment may repeat every three weeks for up to ten courses.
• Patients in group three will receive a one-hour infusion of docetaxel once in week one. They will also receive capecitabine by mouth twice a day in weeks one and two. Treatment may repeat every three weeks for up to four courses. Patients will then receive infusions of doxorubicin and cyclophosphamide. Treatment may repeat every three weeks for up to four courses. After finishing chemotherapy, patients will undergo lumpectomy or mastectomy.
• Patients in group four will receive a 30 to 90 minute infusion of bevacizumab and a one hour infusion of docetaxel once in week one. They will also receive capecitabine by mouth twice-a-day in weeks one and two. Treatment may repeat every three weeks for up to four courses. Patients will then receive an infusion of bevacizumab every three weeks for up to two courses and infusions of doxorubicin and cyclophosphamide every three weeks for up to four courses. After finishing chemotherapy and bevacizmab, patients will undergo lumpectomy or mastectomy. Beginning at least four to six weeks after surgery, patients will receive an infusion of bevacizumab. Treatment may repeat every three weeks for up to ten courses.
• Patients in group five will receive a one-hour infusion of docetaxel once in week one. They will also receive an infusion of gemcitabine once in weeks one and two. Treatment may repeat every three weeks for up to four courses. Patients will then receive infusions of doxorubicin and cyclophosphamide. Treatment may repeat every three weeks for up to four courses. After finishing chemotherapy, patients will undergo lumpectomy or mastectomy.
• Patients in group six will receive a one-hour infusion of docetaxel once in week one. They will also receive an infusion of gemcitabine once in weeks one and two. Treatment may repeat every three weeks for up to four courses. Patients will then receive infusions of doxorubicin and cyclophosphamide. Treatment may repeat every three weeks for up to four courses. During the first two courses of doxorubicin and cyclophosphamide, patients will also receive an infusion of bevacizumab. After finishing chemotherapy and bevacizumab, patients will undergo lumpectomy or mastectomy. Beginning at least four to six weeks after surgery, patients will receive an infusion of bevacizumab. Treatment may repeat every three weeks for up to 10 courses.

Patients will undergo core needle biopsy and tissue sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated periodically for 10 years.

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Randomized, open label multi-center phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer (N063D)

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Monoclonal antibodies, such as trastuzumab or lapatinib can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known which combination chemotherapy regimen given together with trastuzumab is more effective in treating breast cancer.

Eligibility

• Age greater than or equal to 18 years
• Breast cancer that has been removed and has not spread to other parts of the body and also meets the following criteria:
  • Sentinel lymph node biopsy and or removal of lymph nodes from under the arm
  • Must have at least one lymph node that contains cancer or have a large tumor in the breast
  • Must know hormone receptor status of the tumor
  • Must have Her2 positive tumor

Final eligibility is determined by the research team

Treatment/Intervention

• For design 1: Randomization must be performed no longer than 12 weeks from day 1 of the last chemotherapy cycle after obtaining a post-chemotherapy LVEF = 50. Study treatment should start no more than 14 days after randomization.
• For design 2: Randomization must be performed no longer than 6 weeks from day 1 of the last anthracycline-containing chemotherapy cycle after obtaining a post-anthracycline chemotherapy LVEF = 50. Study treatment should start no more than 14 days after randomization and must be concurrent with paclitaxel.