Showing 1 - 10 of 31 Breast Cancers
Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer (INTEGRAL)

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory, triple negative br ... Read more >

Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair

Status: Enrolling

Investigator: Warren Ellsworth

Study Coordinator: Valentina Villarroel

Phone: 346.238.4384

This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft. Addendum 1 (MATCH) establishes a comparat ... Read more >

A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair

Status: Enrolling

Investigator: Aldona Spiegel

Study Coordinator: Valentina Villarroel

Phone: 346.238.4384

This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft. Addendum 1 (MATCH) establishes a comparat ... Read more >

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast

Status: Open Not Enrolling

Investigator: Hanh Mai

Study Coordinator: Jawairia Jawed

Phone: 346.356.3603

Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. ... Read more >

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/?Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/?HER2-negative Breast Cancer

Status: Enrolling

Investigator: Kai Sun

Study Coordinator: Jawairia Jawed

Phone: 346.356.3603

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembro ... Read more >

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy

Status: Open Not Enrolling

Investigator: Sandra Templeton

Study Coordinator: Juan Morales Viera

Phone: 786.803.2333

This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes th ... Read more >

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Alexys Brock

Phone: 346.238.4814

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet know ... Read more >

A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Alexys Brock

Phone: 346.238.4814

The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a dru ... Read more >

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab With Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Drugs used in chemothera ... Read more >

A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ? 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. ... Read more >

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Status: Open Not Enrolling

Investigator: Kai Sun

Study Coordinator: Jawairia Jawed

Phone: 346.356.3603

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III hist ... Read more >

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy (CAMBRIA-1)

Status: Enrolling

Investigator: Kai Sun

Study Coordinator: Jawairia Jawed

Phone: 346.356.3603

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitiv ... Read more >

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Status: Open Not Enrolling

Investigator: Hanh Mai

Study Coordinator: Jawairia Jawed

Phone: 346.356.3603

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disea ... Read more >

A Study of DB-1303/?BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

Status: Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohis ... Read more >

Acupuncture Trial

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Alexys Brock

Phone: 346.238.4814

A single arm pilot study of 20 patients will be used to determine the feasibility of EA as a treatment for cancer survivors who have been treated with curative intent, but who have persistent CIPN for ?3 months after the cancer treatment is comp ... Read more >

Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Tumor tissue collected from biopsy before surgery ... Read more >

B49: Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Alexys Brock

Phone: 346.238.4814

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. ... Read more >

Capivasertib + CDK4/?6i + Fulvestrant for Advanced/?Metastatic HR+/?HER2- Breast Cancer (CAPItello-292) (CAPItello-292)

Status: Enrolling

Investigator: Kai Sun

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unre ... Read more >

Converting HR Breast Cancer Into an Individualized Vaccine

Status: Open Not Enrolling

Investigator: Jenny Chang

Study Coordinator: Rabia Hashmani

Phone: 346.238.5894

Hormone receptor positive breast cancer HRBC is the most common cause of BC-related death. HRBC is characterized by a non-immunogenic microenvironment and consequently, modest responses have been observed with immune checkpoint blockade ICB alon ... Read more >

Fulvestrant Plus Abemaciclib With or Without Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

Status: Enrolling

Investigator: Polly Niravath

Study Coordinator: Alexys Brock

Phone: 346.238.4814

The study will investigate if a one month drug holiday from the CDK4/6 inhibitor drug, abemaciclib, will restore the body's sensitivity to the drug and make the subsequent treatment of abemaciclib plus fulvestrant more effective. ... Read more >

IMPACT ON SURVIVAL OF FAITH-BASED SPIRITUAL CARE OR PSYCHOTHERAPY COMBINED WITH PALLIATIVE CARE VERSUS PALLIATIVE CARE ALONE IN PATIENTS WITH NON-CURATIVE MALIGNANCIES

Status: Enrolling

Investigator: Hanh Mai

Study Coordinator: Natolie Hamilton

Phone: 469.267.9275

This phase III clinical trial will evaluate the impact on survival of adding chaplain-provided spiritual care or psychotherapy/meditation to standard-of-care (SOC) and palliative measures, plus chemotherapy if recommended, and comparing it with ... Read more >

Multicenter Phase I/Ib Trial of Olaparib in Combination With Vorinostat in Patients With Relapsed/Refractory and/or Metastatic Breast Cancer

Status: Enrolling

Investigator: Polly Niravath

Study Coordinator: Alexys Brock

Phone: 346.238.4814

This is a Phase I/Ib study testing the safety and preliminary efficacy of olaparib and vorinostat when used together in participants with relapsed/refractory and or metastatic breast cancer. Cancer cells grow in an uncontrolled manner and this c ... Read more >

Multicenter Phase II Trial of Durvalumab (MEDI4736) With Trastuzumab and Pertuzumab Combination in HER2-Enriched and HER2-Amplified Breast Cancer (DTP Trial)

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Jawairia Jawed

Phone: 346.356.3603

The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer. ... Read more >

PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). ... Read more >

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

Status: Enrolling

Investigator: Kai Sun

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with ... Read more >

REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Alexys Brock

Phone: 346.238.4814

This study is investigating whether breast cancer patients who experience vaginal dryness while on anti-estrogen treatment could benefit from either vaginal estrogen or from a vaginal moisturizer called Replens. ... Read more >

Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (PRESERVE-001)

Status: Open Not Enrolling

Investigator: Kai Sun

Study Coordinator:

Phone:

This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with a ... Read more >

Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Status: Open Not Enrolling

Investigator: Sindhu Nair

Study Coordinator: Misbah Baloch

Phone: 713.790.3311

This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER) ... Read more >

SWOG 1007

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exem ... Read more >

TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

Status: Enrolling

Investigator: Bin Teh

Study Coordinator: Natolie Hamilton

Phone: 469.267.9275

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiati ... Read more >

The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib

Status: Enrolling

Investigator: Kai Sun

Study Coordinator: Jawairia Jawed

Phone: 346.356.3603

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trast ... Read more >