Breast Cancer

Clinical Trials

Below is a list of Breast Cancer clinical trials from the clinical trials database at Mayo Clinic.

This list includes only trials about which Mayo researchers choose to publish information. Mayo Clinic may be conducting other trials which are not in this database. Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.

A Phase III Study of Letrozole (Femara) Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen (Novaldex)
This research study is being done:
- to find out if it is helpful to get letrozole for an additional five years or to stop after the first five years of aromatase inhibitor treatment.
- to find out what the long term side effects (good or bad) of letrozole might be and if they outweigh any benefits of continuing treatment with letrozole.
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N063D/BIG 2-06, ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study - A randomised, 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
Patients are being asked to take part in this research study because they have early stage HER2 positive (HER2+) breast cancer that has been surgically removed. Patients will also have received some chemotherapy to treat the cancer. The most common treatment used in the United States and Canada is doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) - sometimes referred to as "AC," but it's possible the patient will have received another treatment.
The purpose of this research study is to:
- Find out what effects (good and bad) the study treatment has on the patient and their cancer.
- Compare four different study treatment combinations to see if one is better
- Find out what effects this study has on a patient's quality of life.

Because of recent research by North Central Cancer Treatment Group (NCCTG), the
standard treatment for HER2+ breast cancer now includes trastuzumab (Herceptin).
However, not all patients with HER2+ breast cancer do better with trastuzumab, so
investigators are trying to find out why.

GW572016 (lapatinib, brand name: Tykerb) is a new drug that is taken every day by mouth. Lapatinib is considered "investigational" in this study. "Investigational" means that the U.S. Food and Drug Administration (FDA) has not approved lapatinib as a treatment for early breast cancer.

This study is comparing trastuzumab to lapatinib and each drug alone to two
combinations of trastuzumab and lapatinib. The four treatments being studied here are:
- Group 1 - Standard treatment of trastuzumab alone for one year
- Group 2 - Lapatinib alone for one year
- Group 3 - Trastuzumab for 12 weeks followed by a six week break, and then
lapatinib for 34 weeks
- Group 4 - Trastuzumab and lapatinib together for one year
The true benefit of taking lapatinib either instead of trastuzumab or with trastuzumab is not known.
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06-213 A Phase 2 Study of Lapatinib (Tykerb) in Combination with Trastuzumab (Herceptin) in Patients with HER2-Positive, Metastatic Breast Cancer
Patients are being asked to take part in this research study because they have breast cancer that has spread to other parts of their body. This research study is evaluating a drug called lapatinib as a possible treatment for breast cancer. In this study, the drug is combined with trastuzumab (Herceptin), which is a standard treatment for breast cancer. The FDA (the U.S. Food and Drug Administration) has not yet approved this drug combination for use for this type of cancer. Lapatinib is approved for use in this type of cancer when used in combination with capecitabine (Xeloda), a type of chemotherapy. Therefore, the use of the combination of Lapatinib and Herceptin is investigational. The purpose of this research study is to determine the effects that the combination of the study drug (lapatinib) plus Herceptin has on a patient and their cancer. Lapatinib is a compound that may stop cancer cells from growing.

This drug has been used in other research studies of patients with breast cancer and information from those research studies suggests that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer in this research study. In this research study, the staff are studying the effects of the combination of lapatinib plus Herceptin in patients with breast cancer that has spread outside of the breast. The researchers are also studying whether positron emission tomography (PET/CT) scans can predict which patients will benefit from the study treatment. Finally, the research staff are studying genes and proteins in the patient's tumor tissue that may lead to sensitivity or resistance to Herceptin and to the combination of Herceptin plus lapatinib. The researchers are also studying genes and proteins in the patient's tumor tissue to try to understand the changes that might occur to allow cancers to spread and/or to grow.
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A Phase III Study of Pilocarpine (Salogen) as Treatment for Vaginal Dryness in Post-Menopausal Women
This study is being done to see if pilocarpine will help with vaginal dryness. Pilocarpine is a drug that has been used to treat dry eyes and dry mouth. Patients are being asked to take part in this research study because they are post-menopausal and are experiencing vaginal dryness, and they have a history of breast cancer or do not want to take vaginal estrogen for a fear of increased risk of breast cancer.
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Bisphosphonates as Treatment in Breast Cancer (S0307)
This study is investigational and is being done to find out if adding a drug (a bisphosphonate) to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body. Bisphosphonates are a group of drugs that have strong effects on the bones and have been shown to strengthen the bones in many patients who take them. This study will compare three study drugs, ibandronate, clodronate, and zoledronic acid in breast cancer.
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Combined Chemotherapy and Hormone Therapy for Individuals with a Low Risk of Cancer Recurrence after Ten Years: The TAILORx Trial
This study is being done to:
- Determine whether patients who have a tumor with a 10 percent chance of their tumor
recurring (coming back following treatment) after 10 years benefit from
chemotherapy
- Determine whether patients who have a 5 percent chance of their tumor recurring
(coming back following treatment) after 10 years have a very low risk of recurrence with hormonal therapy alone (and do not need chemotherapy to reduce their risk of recurrence)
- Create a tissue and blood specimen bank that includes specimens from all women who participate in this study
- Collect follow-up information regarding the health status of all women who
participate in the study for 20 years in order to evaluate new diagnostic tests in the
future as they develop that may predict benefit or side effects from certain cancer
treatments.
Patients are being asked to take part in this trial because they have breast cancer that is estrogen receptor and/or progesterone receptor positive that has not spread to the auxiliary lymph nodes. Although the patients have received surgical treatment for their cancer, there is a chance that they may have a future recurrence of the cancer in the breast, chest wall, or other parts of their body. Based on researchers' current knowledge about the treatment of breast cancer, the doctors believe that patients in this study are candidates for chemotherapy in addition to hormonal therapy in order to reduce their risk of recurrence, a recommendation that is consistent with established guidelines for treatment of this type of breast cancer.
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Comparison of Types of Radiation Techniques for Women with Early Stages of Breast Cancer (B-39)
Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. The purpose of this study is to see if partial breast irradiation (PBI) is as good as or better than whole breast irradiation (WBI) in keeping cancer from coming back in the breast. WBI is a standard treatment after a lumpectomy. WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. PBI is radiation therapy given only to the area of the breast where the cancer was removed. PBI is given 2 times a day on 5 days. PBI may be given over a period of 5 to 10 days. There are 2 different methods of PBI that are being used in this study: multi-catheter brachytherapy and 3-D conformal external beam irradiation.
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Doxorubicin, Cyclophosphamide, Paclitaxel, Granulocyte Colony-Stimulating Factor (GCS-F), Pegfilgrastim as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer (S0221)
This research study is being done to compare the effects (good and bad) of four different treatments (or "regimens") for breast cancer. All of these treatments include the same drugs [doxorubicin, cyclophosphamide, paclitaxel, granulocyte colony-stimulating factor (GCS-F), pegfilgrastim] given in different ways and on different schedules. All of the treatments use commerciall available medicines that are known to be effective for treating breast cancer.
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EGF107671, A Phase II Study of Lapatinib (Tykerb) plus Topotecan (Hycamtin) or Lapatinib plus Capecitabine (Xeloda) in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy
Patients are being asked to take part in this research study because they have metastatic breast cancer which has spread to their brain. This study is being performed to determine how safe and effective lapatinib would be when combined with either capecitabine (also called Xeloda) or with topotecan (also called Hycamtin) in treating this type of cancer.
Lapatinib (also called Tykerb) in combination with a drug called capecitabine, has been
approved by the U.S. Food and Drug Administration (FDA) to treat patients with metastatic breast cancer. Capecitabine and topotecan have both been approved by the FDA for treating cancer. However, lapatinib and topotecan together have not been approved for treating this type of cancer. This combination can only be used by doctors approved to conduct research.


All three of these drugs work differently, and it is hoped that one of these two combinations of medicines will further slow or stop the patient's cancer from growing. However, this cannot be guaranteed. The study is also being performed to test the safety of these two different combinations of drugs to see if they have any side effects, how severe these side effects may be, and how often they occur. The study doctor will carefully monitor the patient for side effects throughout the study.
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Estrogen-DNA Adducts in Breast, Urine and Serum (Blood) as Biomarkers of Breast Cancer Risk
This study is being done to:

Low/ Average Risk Patients:
1. Measure the level of certain hormones, enzymes and cellular products in urine and serum (blood) samples obtained from women who are low or average risk for developing breast cancer
2. Determine whether the level of these products present in urine and blood samples may be related to risk of developing breast cancer

High Risk/ Recently Diagnosed Breast Cancer Patients
1. Measure the level of certain hormones, enzymes and cellular products in breast nipple fluid samples, urine and serum (blood) samples obtained from women who are high risk for developing breast cancer and in women with a recent new diagnosis of breast cancer
2. Determine whether the level of these products present in urine, blood, and nipple fluid samples may be related to risk of developing breast cancer
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Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer (IBCSG 25-02)
This research study is being done to:

• see if the combination of ovarian function suppression using a GnRH analogue plus tamoxifen is better at stopping the return of breast cancer than the combination of ovarian function suppression using a GnRH analogue plus exemestane;
• compare the effects (good and bad) of exemestane to the effects of tamoxifen.
• see how the treatment affects how well the patient feels.
• see if there are any effects (good and bad) that happen after treatment has stopped.

Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane Adjuvant Therapies for Pre-Menopausal Women with Endocrine Responsive Breast Cancer (IBCSG 24-02)
This research study is being done to:

• see if ovarian function suppression [OFS] plus giving tamoxifen or exemestane is better at stopping the return of breast cancer than just giving tamoxifen in pre-menopausal women. Ovarian function suppression [OFS] shuts down the ovaries and stops them from making hormones such as estrogen.
• see if a newer hormone drug called exemestane plus OFS is better than tamoxifen plus OFS.
• see what are the good and bad side effects of the treatment.
• see how the treatment affects how well the patient feels.
• see if there are any effects (good and bad) that happen after treatment has stopped.

Exemestane Versus Anastrozole with or without Celecoxib in Postmenopausal Women with Receptor Positive Postmenopausal Breast Primary Cancer (MA.27)
This research study is being done to:

• Compare the ability of exemestane and anastrozole to prevent breast cancer from coming back.
• Compare their side effects (good and bad) on you.

Genetics Study for Women with Breast Cancer and Starting Anastrozole (Arimidex) Treatment (MC0532)
This study is being done to examine how a woman's genes affect the way her body responds to anastrozole treatment. Researchers will look at changes in hormone levels, bone density and mammograms.
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Phase 2 Study of Fulvestrant (Faslodex) and Bevacizumab (Avastin) in Patients with Metastatic Breast Cancer Previously Treated with an Aromatase Inhibitor
Patients are being asked to take part in this research study because they have breast cancer that has spread to other parts of their body (also called metastatic breast cancer). This study is being done to find out what effects, good and/or bad, the combination of fulvestrant (Faslodex®) and bevacizumab (Avastin®) has on a patient and their metastatic breast cancer.
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Phase II Study of Paced Breathing for Hot Flashes
Patients are being asked to take part in this research study because they have hot flashes and they
would like to have fewer and/or less severe hot flashes. Paced breathing is a kind of rhythmic and controlled breathing. Practicing paced breathing might be helpful in controlling the hot flashes participants experience.
This study is being done to:
- Look at what effects (good and bad) the paced breathing exercises will have on the patient and
their hot flashes.
- Look at what effects (good and bad) the paced breathing exercises will have on their mood, tiredness, sleep quality, and blood pressure.
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Phase III Study of Cyclophosphamide (Cytoxan) and Doxorubicin (Adriamycin) (CA) (4 Cycles) Versus Paclitaxel (Taxol) (4 Cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes
This study is being done to:
- Compare the effects (good and bad) of the standard chemotherapy, cyclophosphamide and doxorubicin (CA) with the chemotherapy drug, paclitaxel. These drugs are given after surgery, and this treatment is called adjuvant therapy.
- Compare the effects (good and bad) of eight weeks of treatment with 12 weeks of treatment using CA or paclitaxel.
CA treatment (given into a vein every two or three weeks for four treatments) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer. Paclitaxel given after combination chemotherapy has been approved for the adjuvant treatment of breast cancer that has spread to the lymph nodes. Paclitaxel is also approved for the treatment of breast cancer that has grown or that has spread to other parts of the body after previous chemotherapy. The use of paclitaxel as an adjuvant treatment for breast cancer that has not spread to the lymph nodes as used in this study, are considered to be investigational or research.
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RC0731, Phase II Randomized Study of Sorafenib (Nexavar) Compared to Placebo when Administered in Combination with Aromatase Inhibitors (letrozole, anastrozole, or exemestane) for Postmenopausal Women with Metastatic Breast Cancer
Patients are being asked to take part in this research study because they are a postmenopausal woman with metastatic breast cancer. This study is being done to see if sorafenib is better than a placebo (inactive drug) when used with a standard of care aromatase inhibitor (letrozole, anastrozole, or exemestane).
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Safety of Heart Function in the Early Diagnosed HER2+ Breast Cancer Patients when Treated with Chemotherapy plus Trastuzumab (Herceptin) and Lapatinib (Tykerb)
This study will:
-See if taking lapatinib (Tykerb) with trastuzumab (Herceptin) in the treatment of early-stage breast cancer works as well or better than it does in the treatment of metastatic breast cancer.
-Look at the safety of taking lapatinib with a standard treatment regimen
-Find out what effects (good and bad) the study regimen has on the patient and their cancer
-Look at disease-free and overall survival of patients receiving the study treatment
-Compare two questionnaires that look at the patient's quality of life

This study will also look at research blood samples to:
-See if tumor cells circulate in the blood
-Compare 2 methods for detecting these circulating tumor cells
-Look at levels of HER1 and HER2 in relationship to the therapy the patient is receiving and their response to the treatment
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Study of XRP9881 in Combination with Capecitabine (Xeloda), in Metastatic Breast Cancer Patients with Disease Progressing After Anthracycline and/or Taxane Therapy
Patients are being invited to participate in this clinical research study because they have breast cancer that has gotten worse even with prior treatment with taxanes [eg, docetaxel (Taxotere) or paclitaxel (eg, Taxol, Abraxane)], or anthracyclines [eg, doxorubicin (Adriamycin) and epirubicin (eg, Ellence)]. Their doctor has determined that further treatment for the patient's cancer is needed. Standard treatment for their condition would normally include chemotherapy. Capecitabine (Xeloda) is a chemotherapy drug approved for the treatment of breast cancer such as the patients' in this study. XRP9881 is an experimental research drug, related to docetaxel and paclitaxel, which is being offered to the patient together with capecitabine as part of this clinical study.
The purpose of Part One of this clinical study is:
- To find out the highest dose of XRP9881 in combination with Xeloda that can be given without causing bad side effects,
And
To determine what effects (good and bad) these drugs have on the patient and their type of breast cancer.
The purpose of Part Two of this clinical study is to:
- Find out if the combination of XRP9881 with capecitabine is a safe and helpful treatment for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel
- Determine what effects (good and bad) these drugs have on the patient and their type of breast cancer
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Treatment with Examestane, an Aromatase Inhibitor, versus Placebo, for Postmenopausal Women at High Risk for Developing Breast Cancer (MAP 3)
This research study is being done to test whether exemestane, an investigational drug, will decrease the number of people diagnosed with invasive breast cancer in women at high risk for developing breast cancer. Exemestane is an "investigational drug". The word "investigational" means that the drug has not been approved by the Food and Drug Administration (FDA) for this use in the United States or Canada.
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Z1031, A Phase 3 Trial Comparing 16 to 18 Weeks of Neoadjuvant (Given Before Surgery) Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Stage 2 and 3 Estrogen Receptor Positive Breast Cancer
Patients are being asked to take part in this study because they have a kind of breast cancer that is affected by the levels of hormones in their body. Patients are also postmenopausal, which can affect the way this kind of cancer responds to certain kinds of treatment. The surgical options do not include the kind of surgery known as breast conserving treatment (or lumpectomy), or in some cases, mastectomy, at this time.

Breast conserving treatment (lumpectomy) is a type of surgery in which the cancer, plus a small amount of surrounding normal tissue, is removed. Mastectomy is a surgical procedure in which the entire breast is removed. Researchers have been studying breast cancer to learn the best way to treat the disease. Chemotherapy (treatment with anticancer drugs) is commonly given before surgery to shrink breast tumors. The therapy in this research study consists of one of three drugs of a type called hormone therapy (a drug used to lower the level of the hormone estrogen). The hormone therapies being tested in this study are exemestane, anastrozole, and letrozole. Research has shown that reducing the amount of the hormone estrogen that gets to the cancer in postmenopausal women with hormone-dependent breast cancer can shrink the breast tumor before surgery.

This study is being done to find out whether it is better to receive exemestane, anastrozole, or letrozole to improve the chance that the breast cancer will get smaller before surgery.
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