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Title: An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4/6 Inhibitor Plus Letrozole In Participants Over 18 Years of Age With Hormone Receptor (HR)-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Who Have Not Received Any Prior Systemic Anticancer Treatment for Advanced/Metastatic Disease (FourLight-3)
Brief Title: Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
Brief Summary: The purpose of this study is to determine the safety and efficacy of PF-07220060 with
letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib
with letrozole) in people with breast cancer:
- HR-positive (breast cancer cells that need estrogen or progesterone to grow)
- HER2-negative (cells that have a small amount or none of a protein called HER2 on
their surface);
- locally advanced (that has spread from where it started to nearby tissue or lymph
nodes) or metastatic disease (the spread of cancer to other places in the body)
- who have not received any prior systemic anti-cancer treatment for
advanced/metastatic disease.
Approximately half of the participants will receive PF-07220060 plus letrozole while the
other half of participants will receive the investigator's choice of treatment plus
letrozole.
The study team will monitor how each participant is doing with the study treatment during
regular visits at the study clinic.
For info regarding 25-108
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
Brief Title: Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
Brief Summary: This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy
without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage
triple negative breast cancer. Paclitaxel is in a class of medications called
anti-microtubule agents. It stops cancer cells from growing and dividing and may kill
them. Carboplatin is in a class of medications known as platinum-containing compounds. It
works in a way similar to the anticancer drug cisplatin, but may be better tolerated than
cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells.
Cyclophosphamide is in a class of medications called alkylating agents. It works by
damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also
lower the body's immune response. Docetaxel is in a class of medications called taxanes.
It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an
anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab
may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. Shorter treatment without anthracycline chemotherapy may work the same as the
usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
For info regarding 25-101
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)
Brief Title: A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Brief Summary: The primary goal of this study is to evaluate the effectiveness of elacestrant versus
standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive
(ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high
risk of recurrence.
For info regarding 24-676
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score = 25 (OFSET)
Brief Title: Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
Brief Summary: This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors
and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1
patients).
For info regarding 24-635
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)
Brief Title: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
Brief Summary: The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus
camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1,
BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH
non-amplified) advanced breast cancer
For info regarding 24-573
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: TRADE-DXd: A phase II non-comparative trial of datopotamab deruxtecan (Dato-DXd) or trastuzumab deruxtecan (T-DXd) in patients with metastatic HER2-negative (HER2-low or HER2-0) breast cancer after progression on prior antibody drug conjugate therapy
Brief Title: TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Brief Summary: The purpose of this study is to test the safety and effectiveness of the sequence of two
investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or
datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment
works in treating HER2-negative (HER2-low or HER2-0) metastatic breast cancer.
The names of the study drugs involved in this study are:
- Datopotamab deruxtecan (a type of antibody drug conjugate)
- Trastuzumab deruxtecan (a type of antibody drug conjugate)
For info regarding 24-251
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase Ib study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2-associated metastatic HER2-negative breast cancer
Brief Title: Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
Brief Summary: This research is being done to evaluate the safety and tolerability of the new drug,
axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer
1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer.
The names of the study drugs involved in this study are:
- Axatilimab (a type of antibody)
- Olaparib (a type of PARP inhibitor)
For info regarding 24-155
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
Brief Title: Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
Brief Summary: 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 pembrolizumab.
Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells to
grow and spread. This trial may help researchers determine if observation will result in
the same risk of cancer coming back as pembrolizumab after surgery in triple-negative
breast cancer patients who achieve pathologic complete response after preoperative
chemotherapy with pembrolizumab.
For info regarding 23-428
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
Brief Title: Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
Brief Summary: The goal of this study is to find out if the experimental product, sacituzumab
govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective
and safe compared to the treatment of physician's choice (TPC) which includes either
pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative
breast cancer that still remains after surgery and pre-surgical treatment.
For info regarding 23-399
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation.
Brief Title: Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Brief Summary: The goal of this clinical trial is to assess the efficacy, safety and tolerability of the
combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for
the treatment of pre- and postmenopausal women and men who have previously received
ribociclib or palbociclib-based treatment and have locally advanced or metastatic
estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast
cancer with an estrogen receptor 1 (ESR1) mutation.
The main question the study aims to answer is:
• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of
fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral
lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant
500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus
oral abemaciclib 150 mg twice a day.
For info regarding 23-206
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A randomized phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for Stage I HER2-positive breast cancer (ATEMPT 2.0)
Brief Title: ATEMPT 2.0: Adjuvant T-DM1 vs TH
Brief Summary: This research study is studying how well newly diagnosed breast cancer that has tested
positive for a protein called HER2 responds using one of two different combination of
HER2-directed therapies as a treatment after surgery.
The name of the study drugs involved are:
- Trastuzumab-emtansine (T-DM1, Kadcyla)
- Trastuzumab SC (Herceptin Hylecta)
- Paclitaxel
For info regarding 21-159
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A single arm phase II study of ADjuvant Endocrine therapy, Pertuzumab, and Trastuzumab for patients with anatomic stage I hormone receptor-positive, HER2-positive breast cancer (ADEPT)
Brief Title: A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
Brief Summary: This research study is studying a combination of HER2-directed therapies (trastuzumab and
pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor
positive breast cancer.
The study drugs involved in this study are:
- A combination of trastuzumab and pertuzumab given as an injection under the skin
(PHESGO)
- Hormonal (endocrine) Treatment
For info regarding 20-347
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older
Brief Title: Trial of a Mammography Decision Aid for Women Aged 75 and Older
Brief Summary: The aim of this study is to test whether an educational pamphlet on mammography designed
for women aged 75 and older improves older women's decision-making around mammography
screening. The investigators aim to show that the educational pamphlet improves older
women's knowledge of the pros and cons or screening and leads to fewer women in poor
health with short life expectancy being screened.
For info regarding 19-707
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Conversation Aid on Mammography Screening to Support Shared Decision Making between Clinicians and Women Aged 75 and Older
Brief Title: A CONVERSATION AID ON MAMMOGRAPHY SCREENING
For info regarding 19-659
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Decisions About Cancer Screening in Alzheimer's Disease
Brief Title: Decisions About Cancer Screening in Alzheimer's Disease
Brief Summary: The Decisions about Cancer screening in Alzheimer's Disease (DECAD) study tests if an
evidence-based decision aid for dementia caregivers can support decision-making about
mammography and improve the quality of medical decision-making about breast cancer
screening. This large randomized controlled trial will recruit up to 450 dyads (900
individual participants) of older women with dementia and a family caregiver, for a goal
of 426 dyad baselines (852 individual participants).
For info regarding 19-592
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A phase 2 study of response-guided neoadjuvant sacituzumab govitecan (IMMU-132) in patients with localized Breast Cancer (NeoSTAR).
Brief Title: Sacituzumab Govitecan In TNBC
Brief Summary: This research study is studying to evaluate sacituzumab govitecan for individuals with
localized triple negative breast cancer (TNBC)
The names of the study drugs involved in this study is:
- Sacituzumab govitecan (SG)
- Pembrolizumab (combination therapy with SG)
For info regarding 19-578
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Prospective Registry to Cure Triple-Negative Breast Cancer in Patients with Early-Stage or Newly Diagnosed Metastatic Disease: The TNBC Registry
Brief Title: The TNBC Registry
For info regarding 18-617
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Role of Contrast Enhanced Spectral Mammography to predict upgrade rates of biopsy proven atypical ductal hyperplasia
Brief Title: Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia
Brief Summary: This research study is studying whether contrast enhanced mammography can predict if
atypical ductal hyperplasia will progress to cancer.
The device involved in this study is:
-Contrast enhanced mammography
For info regarding 17-694
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Real-time assessment of breast cancer surgical specimen margins with nonlinear microscopy
Brief Title: Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
Brief Summary: This research is studying a new investigative imaging instrument called a nonlinear
microscope (NLM). A nonlinear microscope can produce images similar to an ordinary
pathologist's microscope, but without first processing tissue to make slides. This study
will determine if a NLM can be used to evaluate tissue during lumpectomy surgery for
breast cancer in order to reduce the probability that standard pathologic examination of
the specimen after the end of the operation will find close or positive margins, thus
possibly requiring the patient to have additional breast surgery.
For info regarding 16-145
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Impact of breast MRI in clinical evaluation and practice: audit of MR imaging data
Brief Title: IMPACT OF BR MRI IN CLINICAL EVAL AND PRACTICE
For info regarding 14-262
please contact BIDMC Group Mailbox Radiology Imaging Group M at
RadiologyImagingTrials@bidmc.harvard.edu
Title: Tissue Repository for Individuals at High Risk of Cancer; ACT for Others
Brief Title: ACT FOR OTHERS
For info regarding 10-458
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Characterization of Estrogen Receptor Positive Breast Cancer in BRCA 1
Brief Title: Characterization of Estrogen Receptor Positive Bre
For info regarding 07-334
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Collection of Specimens and Clinical Data for Patients with Breast Cancer
Brief Title: SPECIMEN COLLECTION IN MET BREAST
For info regarding 05-246
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Evaluation of Tumormetrics in Determining Tumor Size and Response to Treatment
Brief Title: Evaluation of Tumormetrics in Determining Tumor
For info regarding 03-383
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu