Select Ongoing Trials Currently Enrolling Patients with Breast Cancer

October 2016, Vol 6, No 10 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with breast cancer for inclusion in investigations of new therapies and new regimens of existing treatments for patients with breast cancer. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov.

1 Efficacy and Safety of Olaparib as Adjuvant Treatment for Patients with BRCA1/2 Mutations and HER2-Negative Breast Cancer

The purpose of this randomized, double-blind, phase 3 clinical trial is to evaluate the efficacy and safety of olaparib compared with placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high-risk HER2-negative primary breast cancer who finished definitive local treatment and neoadjuvant or adjuvant chemotherapy. Patients aged 18 to 130 years may be eligible for enrollment if they have histologically confirmed nonmetastatic primary invasive breast cancer, no evidence of metastatic breast cancer, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 if other criteria are met. Eligible patients will be randomized to receive oral olaparib 300 mg twice daily, or a matching administration of placebo.

The primary outcome measure is invasive disease−free survival. The secondary outcome measures include overall survival (OS), distant disease−free survival, and the treatment’s effect on the incidence of new primary contralateral breast cancers, ovarian cancer, fallopian tube cancer, and peritoneal cancer. Adverse events and the safety and tolerability of olaparib will also be assessed. This study expects to enroll 1500 patients at multiple locations across the United States and abroad. For more information, contact the AstraZeneca Clinical Study Information Center at 877-240-9479 or information.center@astrazeneca.com. The NLM Identifier is NCT02032823.

2 Safety and Efficacy of Eribulin in Combination with Pembrolizumab for Metastatic Triple-Negative Breast Cancer

The objective of this phase 1/2, single-group, open-label clinical trial is to evaluate the safety and efficacy of eribulin mesylate in combination with pembrolizumab to treat patients with metastatic triple-negative breast cancer who previously received 0 to 2 chemotherapy regimens in the metastatic setting. Patients aged ≥18 years with a life expectancy of ≥3 months who have metastatic triple-negative breast cancer and have previously received 0 to 2 lines of chemotherapy in the metastatic setting may be eligible for enrollment if other criteria are met. All eligible patients will be given intravenous eribulin mesylate on days 1 and 8 of each 21-day cycle, and pembrolizumab on day 1 of each 21-day cycle. Both drugs will be administered in the presence of clinical benefit until intercurrent illness, unacceptable toxicity, or disease progression occurs, or until the patient withdraws his or her consent.

The primary outcome measures are the dose-limiting toxicity and the objective response rate. The secondary outcome measures include progression-free survival (PFS), OS, and the duration of response. This study plans to enroll 95 patients at multiple locations across the United States. For more information, contact Med Info at 888-274-2378. The NLM Identifier is NCT02513472.

3 Safety, Tolerability, and Efficacy of VT-464 in Patients with Advanced Breast Cancer

The purpose of this nonrandomized, parallel-assignment, open-label, phase 1/2 clinical trial is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of VT-464, a lyase-selective inhibitor of cytochrome P450 17, in patients with advanced breast cancer. Patients aged ≥18 years who have histologic or cytologic evidence of invasive breast cancer, an ECOG performance status score of 0 or 1, and who have not received palliative radiotherapy within 4 weeks of entering the study may be eligible for enrollment if other criteria are met. All eligible patients will be given VT-464 daily with an evening meal in 28-day cycles.

The primary outcome measures are to define dose-limiting adverse events and to determine the maximum tolerated dose of VT-464. The secondary outcome measures are the pharmacokinetics of VT-464 and the efficacy of VT-464 as measured by overall response rate, PFS, and the clinical benefit rate. This study plans to enroll 110 patients at mul­tiple locations across the United States. For more information, contact Joel Eisner, PhD, at jeisner@innocrinpharma.com, or Keishea Williams at 919-799-2037 or kwilliams@innocrinpharma.com. The NLM Identifier is NCT02580448.

4 Adjuvant Endocrine Therapy with/without Palbociclib for HR-Positive, HER2-Negative Early Breast Cancer

This prospective, multicenter, randomized, open-label, phase 3 clinical trial is evaluating the addition of 2 years of palbociclib use to standard adjuvant endocrine therapy for patients with hormone receptor (HR)-positive and HER2-negative early breast cancer. Patients aged ≥18 years who have histologically confirmed estrogen receptor (ER)-positive or progesterone receptor (PR)-positive, HER2-negative early invasive breast cancer and an ECOG performance status score of 0 or 1 may be eligible for enrollment if other criteria are met. For ≥5 years, eligible patients will be randomized to receive standard adjuvant endocrine therapy with or without palbociclib.

The primary outcome measure is invasive disease–free survival. The secondary outcome measure is to compare the safety of using palbociclib plus adjuvant endocrine therapy with the use of adjuvant endocrine therapy alone for 2 years. This study expects to enroll 4600 patients at multiple locations across the United States and abroad. For more information, contact Monica Bertagnolli, MD, at pallas_aft@alliancefoundationtrials.org. The NLM Identifier is NCT02513394.

5 Fulvestrant with/without Ribociclib in Patients with HR-Positive, HER2-Negative Breast Cancer

The objective of this double-blind, parallel-assignment, randomized, phase 2 clinical trial is to determine whether there is sustained benefit for patients with metastatic HR-positive, HER2-negative breast cancer that has progressed after treatment with an aromatase inhibitor plus a cyclin-dependent kinase (CDK)4/6 inhibitor to continue receiving a CDK4/6 inhibitor when they switch to therapy with fulvestrant with or without ribociclib. Patients aged ≥18 years who have histologically or cytologically confirmed unresectable or metastatic breast cancer and an ECOG performance status score of 0 or 1 may be eligible for enrollment if other criteria are met. Patients will be randomized to receive injectable fulvestrant plus oral placebo or ribociclib.

The primary outcome measure is the percentage of patients whose disease remains progression-free at 24 weeks. The secondary outcome measure is the overall response rate of the group receiving fulvestrant plus ribociclib. This study expects to enroll 132 patients at multiple locations across the United States. For more information, contact Kevin Kalinsky, MD, MS, at 212-305-1945 or KK2693@cumc.columbia.edu. The NLM Identifier is NCT02632045.

6 Efficacy of Adjuvant Endocrine Therapy with/without Everolimus for Patients with Breast Cancer

This randomized, double-blind, phase 3 clinical trial assesses the efficacy of giving patients with breast cancer hormone therapy with or without everolimus. Patients aged ≥18 years who have histologically confirmed, ER-positive or PR-positive, HER2-negative invasive breast cancer, and for whom standard adjuvant endocrine therapy is planned may be eligible for enrollment if other criteria are met. All patients will be randomized to receive an approved endocrine therapy for 2 to 5 years, with the addition of placebo or everolimus for 1 year barring any evidence of disease progression or unacceptable toxicity.

The primary outcome measure is invasive disease−free survival over a time frame of 10 years. The secondary outcome measures are OS, distant recurrence−free survival, and toxicity, which will all be assessed for up to 10 years. This study plans to enroll 1900 patients at multiple locations across the United States. For more information, contact Megan Hardin at 210-614-8808, ext 1014, or mhardin@swog.org. The NLM Identifier is NCT01674140.

7 Efficacy and Tolerability of Carboplatin and Paclitaxel with/without Veliparib for HER2-Negative Breast Cancer

This phase 3, randomized, double-blind, parallel-assignment clinical trial evaluates the efficacy and tolerability of carboplatin and paclitaxel in combination with veliparib or placebo to treat patients with HER2-negative, metastatic or locally advanced, unresectable, BRCA-associated breast cancer. Patients aged 18 to 99 years with histologically or cytologically confirmed breast cancer that is locally advanced or metastatic, HER2-negative, and unresectable, and who have suspected deleterious or deleterious BRCA1 or BRCA2 germline mutations may be eligible for enrollment if other criteria are met. Patients will be randomized to receive carboplatin and pac­litaxel plus placebo or veliparib.

The primary outcome measure is PFS. The secondary outcome measures include OS, clinical benefit rate, and objective response rate. Changes in quality of life and ECOG performance status scores will also be measured. This study expects to enroll 500 patients at multiple locations across the United States and abroad. For more information, contact Andrew Coates, BS, at 847-937-8266 or andrew.coates@abbvie.com, or Melissa Shah, BS, at 847-938-3885 or melissa.shah@abbvie.com. The NLM Identifier is NCT02163694.

8 Exemestane with/without Entinostat in Patients with Recurrent HR-Positive Breast Cancer

The objective of this randomized, parallel-assignment, double-blind, phase 3 clinical trial is to compare the efficacy of treating patients with HR-positive breast cancer with exemestane as monotherapy versus in combination with entinostat. Patients aged ≥18 years with histologically confirmed ER-positive or PR-positive breast cancer, an ECOG performance status score of 0 or 1, and the ability to swallow tablets may be eligible for enrollment if other criteria are met. Patients will be randomized to receive exemestane in combination with entinostat or placebo.

The primary outcome measures are OS and PFS. The secondary outcome measures are the incidence of toxicity, objective response, and the time to treatment deterioration. Study adherence, overall score on the Health-Related Quality of Life questionnaire, and changes in protein lysine acetylation will also be measured. This study expects to enroll 600 patients at multiple locations across the United States and abroad. For more information, contact Roisin M. Connolly at 410-955-8804 or jhcccro@jhmi.edu. The NLM Identifier is NCT02115282.

9 Recurrence of Early-Stage Breast Cancer with Cryoablation without a Lumpectomy

This interventional, open-label, single-group clinical trial will examine the efficacy of cryoablation without lumpectomy, as well as its influence on local and distant recurrence of early-stage breast cancer. Women aged ≥65 years who have a diagnosis of invasive ductal breast cancer via core needle biopsy and breast size suitable for safe cryoablation may be eligible for enrollment if other criteria are met. Eligible patients will be treated with the IceSense3 cryoablation procedure.

The primary outcome measure is the local in-breast tumor recurrence rate for up to 5 years. The secondary outcome measures include the complete ablation of a primary tumor ≤60 months after cryoablation, the improvement or maintenance of quality of life, and satisfaction with breast cosmetics. This study plans to enroll 150 patients at multiple locations across the United States. For more information, contact Elisabeth Sadka at 724-623-0333, ext 223, or elisabeth@icecuremedical.com. The NLM Identifier is NCT02200705.

10 Presurgical Letrozole for Postmenopausal Women with Operable Stage I-III Breast Cancer

The purpose of this open-label, single-group clinical trial is to assess how well letrozole works in the treatment of postmenopausal women with stage I to III breast cancer that can be surgically removed. Women aged ≥18 years who have been diagnosed with invasive, resectable stage I to III breast cancer, have no severe illnesses that place them at high risk for operative mortality, and who have an ECOG performance status score of 0 or 1 may be eligible for enrollment if they meet other criteria. Eligible patients will receive oral letrozole once daily for 7 to 21 days if there is no evidence of disease progression or unacceptable toxicity. Within 1 day of their last dose of letrozole, patients will undergo a total mastectomy or segmental resection with lymph node evaluation.

The primary outcome measure is the Ki-67 index in HR-positive breast cancer compared with those that are HR-negative. The secondary outcome measures are the in situ apoptotic effect of letrozole and the identification of a recurrence risk biomarker profile using RNA micro­array. This study expects to enroll 200 patients at 3 locations in Nashville, TN. For more information, contact the Vanderbilt-Ingram Cancer Center Clinical Trials Information Program at 800-811-8480. The NLM Identifier is NCT00651976.

11 Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy

This open-label, single-group clinical trial assesses whether the temporary interruption of endocrine therapy, with the goal of permitting pregnancy, is associated with a higher risk for breast cancer recurrence, and evaluates varying specific indicators related to fertility, pregnancy, and breast cancer biology in young women. Women may be eligible for enrollment if they have received adjuvant endocrine therapy for ≥18 months (≤30 months for early breast cancer); are aged 18 to 24 years; and have no history of hysterectomy, bilateral oophorectomy, or ovarian irradiation, among other criteria. Eligible patients will undergo endocrine therapy interruption after completing between 18 months and 30 months of therapy, including a 3-month washout period between treatment interruption and pregnancy attempt, and up to 2 years of interruption allowing for pregnancy, delivery, and breast-feeding, or the failure to conceive. Endocrine therapy will be resumed and the full duration completed based on individual risk, institutional policy, and the patient’s preference.

The primary outcome measure is a breast cancer−free interval. The secondary outcome measures include pregnancy rates and outcomes, in­formation on menstruation, and breast-feeding patterns. This study expects to enroll 500 patients at multiple locations across the United States and abroad. For more information, contact Olivia Pagani, MD, at olivia.pagani@ibcsg.org. The NLM Identifier is NCT02308085.

12 Axillary Lymph Node Dissection versus Axillary Radiation for Node-Positive Breast Cancer

The objective of this randomized, open-label, parallel-assignment, phase 3 clinical trial is to compare the efficacy of axillary lymph node dissection with axillary radiation therapy as treatment for patients with node-positive breast cancer who are treated with neoadjuvant chemotherapy followed by surgery. Patients aged ≥18 years who have no history of ipsilateral axillary surgery, clinical stage T1 to T3 N1 M0 breast cancer at diagnosis, and an ECOG performance status score of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive axillary lymph node dissection plus nodal radiation therapy, or axillary radiation with nodal radiation therapy.

The primary outcome measure is the recurrence-free interval of invasive breast cancer. The secondary outcome measures are OS and the recurrence of ipsilateral, local, or regional invasive breast cancer. Residual cancer burden will also be measured. This study plans to enroll 2918 patients at multiple locations across the United States. For more information, contact Judy Boughey, MD, at 507-284-3629. The NLM Identifier is NCT01901094.

13 Low-Dose Tamoxifen for Reducing Breast Cancer Risk in Survivors of Radiation-Induced Cancer

The purpose of this double-blind, randomized, parallel-assignment, phase 2 clinical trial is to assess how well low-dose tamoxifen citrate works in reducing breast cancer risk in survivors of radiation-induced cancer. Women aged ≥25 years who have no evidence of active disease from their primary cancer for ≥2 continuous years before registration; exposure to radiation therapy delivered to the chest, axilla, or supraclavicular areas at a cumulative dose of ≥12 Gy by age 40 years; and no bilateral breast implants or status-post bilateral prophylactic mastectomies may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive oral tamoxifen citrate 5 mg daily or 1 oral placebo tablet daily.

The primary outcome measure is the efficacy of low-dose tamoxifen citrate in reducing mammographic breast density. The secondary outcome measures include insulin growth factor levels, biomarker levels, and treatment adherence, defined by the number of pills taken of the total pills prescribed. This study plans to enroll 230 patients at multiple locations across the United States. For more information, contact Kandice Barnett, RN, at 205-638-2127 or survivorshiptrial@peds.uab.edu. The NLM Identifier is NCT01196936.

14 Safety of Mifepristone plus Eribulin in Patients with Metastatic or Locally Advanced Unresectable Triple-Negative Breast Cancer

The purpose of this single-group, open-label, phase 1 clinical trial is to evaluate the safety of using a combination of mifepristone and eribulin to treat patients with metastatic or locally advanced unresectable breast cancer, and to determine the preliminary efficacy of using this combination to treat patients with metastatic or locally advanced unresectable triple-negative breast cancer. Patients aged ≥18 years who have a diagnosis of triple-negative breast cancer that is unresectable and an ECOG performance status score of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive a combination of mifepristone and eribulin.

The primary outcome measure is to determine the maximum tolerated dose and recommended phase 2 dose of the combination of mifepristone and eribulin for patients with metastatic or locally advanced unresectable breast cancer. This study plans to enroll 40 patients at multiple locations across the United States. For more information, contact Rita Nanda, MD, at 773-834-2756 or rnanda@medicine.bsd.uchicago.edu. The NLM Identifier is NCT02014337.