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.

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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A Phase II Study of Trastuzumab-MCCDM1 Administered Intravenously (IV) to Patients with HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving Trastuzumab (Herceptin).
The purpose of this study is to investigate an experimental drug called trastuzumab-
MCC-DM1 (T-DM1) for the treatment of metastatic breast cancer. T-DM1 is an experimental drug, which means it has not been approved by the United States Food and Drug Administration (FDA). This study is being done to learn whether T-DM1 can be given to humans safely and if it can slow or stop further tumor growth or make tumors get smaller in patients with metastatic breast cancer.
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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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A Phase III Trial Evaluating the Effectiveness and Safety of Bevacizumab (Avastin), a Biologic Response Modifier Drug, in Combination with Chemotherapy Treatment in Patients with Previously Treated Metastatic Breast Cancer (cancer that has spread) (RIBBON II).
This study is being done to see if bevacizumab*, when given in combination with a standard-of-care treatment is able to:
- Increase how long people live with metastatic breast cancer that has gotten worse
- Delay tumor growth in people with metastatic breast cancer that has gotten worse
- Shrink tumors in people with metastatic breast cancer, and that has gotten worse
- To find out what effects (good and bad) the bevacizumab (a drug) has on patients and their cancer.

* Bevacizumab has not been approved by the U. S. Food and Drug Administration (FDA) for the treatment 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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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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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 II Study of Dasatinib (BMS-354825) for Advanced ER (Estrogen) / PR (Progesterone) Positive or Her2/neu Positive Breast Cancer
The purpose of this study is to learn what effects (both good and bad) the drug Dasatinib has on the patient and their breast cancer. Dasatinib is currently approved by the Food and Drug Administration (FDA) for use in patients who have chronic myeloid leukemia (CML) and is being studied in subjects who have solid tumor cancer(s). There is limited information on whether it is safe to use or effective for treating recurrent (cancer that has come back), locally advanced or 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 Mometasone Furoate (Elocon) versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy
This study is being done to learn if mometasone furoate (a drug in the form of a cream) is helpful in preventing skin inflammation caused by radiation therapy given to the breast or chest wall as part of cancer treatment, and to find out what effects (good and bad) the drug mometasone
furoate has on a patient's skin inflammation.
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Study of Capecitabine in Combination with Vinorelbine and Trastuzumab for the First or Second-Line Treatment of HER2 + Metastatic Breast Cancer (N0337)
This research study is being done to find out what effects (good and bad) the combination of capecitabine (Xeloda®), vinorelbine (Navelbine®), and trastuzumab (Herceptin®) has on you and your breast cancer.
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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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