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Breast Neoplasms clinical trials

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NCT ID: NCT05067972 Terminated - Breast Neoplasms Clinical Trials

A Study of PF-07260437 in Advanced or Metastatic Solid Tumors

C4431001
Start date: October 7, 2021
Phase: Phase 1
Study type: Interventional

A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.

NCT ID: NCT05067530 Not yet recruiting - Clinical trials for Triple Negative Breast Neoplasms

Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study

CAREGIVER
Start date: January 1, 2022
Phase: Phase 2
Study type: Interventional

CAREGIVER is a prospective, randomized, multicenter, open, five-arm study with unequal allocation ratios of 1:1:2:1:2 (palbociclib : paclitaxel : palbociclib + paclitaxel : carboplatin : carboplatin + paclitaxel). Study will be performed in untreated patients with triple-negative breast cancer (TNBC). Potential candidates without previously established diagnosis of TNBC will be included in a Pre-screening Phase, when a biopsy of breast tumor will be taken to confirm the diagnosis of cancer, select patients with TNBC and collect tissue for translational research.

NCT ID: NCT05065411 Terminated - Clinical trials for Metastatic Breast Cancer

Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

VERU-024
Start date: April 11, 2022
Phase: Phase 3
Study type: Interventional

STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)]. STAGE 2: To demonstrate the efficacy and safety of enobosarm 9 mg QD in combination with abemaciclib 150 mg BID (Enobosarm Combination Group) versus Estrogen Blocking Agent (Control Treatment Group) in the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), androgen receptor positive (AR+) with a AR% nuclei staining ≥40% metastatic breast cancer that have previously experienced disease progression on an estrogen blocking agent plus (palbociclib) as measured by progression free survival (PFS) according to RECIST 1.1 criteria.

NCT ID: NCT05064475 Not yet recruiting - Breast Cancer Clinical Trials

Correlation Between PET/CT Parameters and Tumor Markers in Recurrent Breast Cancer

Start date: October 1, 2021
Phase:
Study type: Observational

Worldwide, breast cancer (BC) is the most frequent type of cancer in women yet, it is associated with relatively lower mortality rates, as it ranks fifth in cancer-related deaths overall, which is attributed to evolution in the treatment of recurrent and metastatic lesions, especially when these lesions were detected early . BC recurrence can occur even 15 years after primary treatment.

NCT ID: NCT05064098 Recruiting - Breast Cancer Clinical Trials

Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients

Start date: June 29, 2021
Phase:
Study type: Observational

This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life.

NCT ID: NCT05064085 Active, not recruiting - Clinical trials for Hormone Receptor-positive Breast Cancer

Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer

Start date: October 12, 2021
Phase: Phase 1
Study type: Interventional

This is a single-center, open-label, phase I study to assess the safety and efficacy of the oral chemotherapy capecitabine in combination with cemiplimab in patients with hormone-receptor-positive (HR+) metastatic breast cancer.

NCT ID: NCT05063786 Active, not recruiting - Clinical trials for Advanced Breast Cancer

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

ALPHABET
Start date: September 14, 2021
Phase: Phase 3
Study type: Interventional

Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.

NCT ID: NCT05063643 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude

Start date: October 2021
Phase:
Study type: Observational

This is a prospective, multicenter, cohort study aiming to explore the cardiotoxicity of targeted therapy for HER-2 positive breast cancer patients who lives in high altitude area. One hundred and thirty two HER-2 positive breast cancer patients who will receive neoadjuvant, adjuvant, or palliative targeted therapy will be enrolled. The cardiotoxicity of targeted therapy will be observed and recorded during the treatment and one year after the end of treatment. The subjects will be stratified by age, baseline cardiac risk factors, and anthracyclines.

NCT ID: NCT05063604 Terminated - Breast Cancer Clinical Trials

Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression

CAMAD
Start date: May 10, 2022
Phase: Phase 2
Study type: Interventional

To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression.

NCT ID: NCT05063136 Recruiting - Breast Cancer Clinical Trials

Adjuvant Metronomic Capecitabine Plus Endocrine Therapy for HR+/HER2- Primary Breast Cancer

Start date: September 28, 2021
Phase: Phase 3
Study type: Interventional

Breast cancer (BC) is one of most prevalent malignant tumors in the world. According to the 2020 edition of the global cancer statistics report, the incidence rate of BC has overtaken lung cancer to become the most commonly diagnosed cancer. In the past three decades, survival of patients with primary BC have been notably improved, mainly due to early detection of the disease and advances in adjuvant treatments such as endocrine therapy, chemotherapy, and anti-HER2 therapy. Patients with HR-positive and HER2-negative primary BC account for approximately 70% of all cases of early breast cancer. Endocrine therapy is the core treatment for this subtype of BC. Tamoxifen, aromatase inhibitor or their sequential administration can reduce the recurrence and mortality of this BC subtype. The results of TEXT/SOFT study showed that, compared with the traditional 5-year tamoxifen treatment, tamoxifen + OFS or aromatase inhibitor + OFS can further improve the survival of HR+/HER2- breast cancer patients. However, for premenopausal BC patients with HR+/HER2-, only 82.5% (tamoxifen plus OFS) and 85.7% (aromatase inhibitor plus OFS) of 5-year DFS were achieved. For postmenopausal BC patients, the 5-year DFS was only about 84% with aromatase inhibitors. Therefore, the survival of HR+/ HER2- BC patients needs to be further improved. Metronomic chemotherapy refers to the use of the minimum effective dose of chemotherapy drugs for long-term, uninterrupted administration to achieve anti-tumor effect. Metronomic chemotherapy has gradually been verified in clinical practice in the past 20 years. In 2020, SYSUCC-001 study has confirmed that capecitabine (650 mg/ m2 bid, for 1 years) can reduce the risk of 5-year DFS events by 36% in TNBC patients in addition to standard treatment. Besides, POTENT study has confirmed that the combination of endocrine therapy and S-1 (for one year) can further reduce the risk of iDFS by 37% in HR+/HER2- BC patients who have completed the standard treatment. Compared with capecitabine, S-1 has no indication for BC and it is not in the recommendation for BC treatment in the guidelines. Therefore, the investigators conduct this study to explore whether adjuvant Capecitabine metronomic chemotherapy for one year can further improve the survival of BC patients with HR+/ HER2- in addition to standard treatment.