EA7211 STRASS II
Short Title: STRASS II
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.
After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
Standard arm:
- Large en-bloc curative-intent surgery within 4 weeks following randomization- Experimental arm
Experimental arm:
-
3 cycles of neoadjuvant chemotherapy starting within 2 weeks following randomization:
- High grade LPS: ADM (doxorubicin) 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m3 Q3 weeks.
- LMS: ADM 75 mg/m2 + DTIC (dacarbazine) 1 g/m2 Q3 weeks
- re-assessment of operability
- curative-intent surgery within 3-6 weeks of last cycle of chemotherapy
Study Number:
EA7211
Study Status:
Enrolling
Treatment Agent:
Surgery, Preoperative chemotherapy
Resources and Links
National Clinical Trial Identified Number: NCT04031677
Disease:
- Retroperitoneal Sarcoma,
- Liposarcoma,
- Leiomyosarcoma
Study Phase:
III
researchcancer@cooperhealth.edu
Article Title
A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)
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EvoPAR-Breast01
Short Title: EvoPAR-Breast01
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.
Participants will be randomised in a 2:2:1 ratio to one of the following intervention groups:
- Arm 1: saruparib (AZD5305) plus camizestrant
- Arm 2: Physician's choice CDK4/6i plus physician's choice ET
- Arm 3: Physician's choice CDK4/6i plus camizestrant Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.
Study Number:
EvoPAR-Breast01
Study Status:
Enrolling
Treatment Agent:
Saruparib (AZD5305), Camizestrant, Abemaciclib, Ribociclib, Palbociclib, Fulvestrant, Letrozole, Anastrozole, Exemestane
Resources and Links
National Clinical Trial Identified Number: NCT06380751
Disease:
- Advanced Breast Cancer
Study Phase:
III
researchcancer@cooperhealth.edu
Article 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)
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Department:
GY036
Short Title: GY036
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.
Study Number:
GY036
Study Status:
Enrolling
Treatment Agent:
Bevacizumab, Olaparib
Resources and Links
National Clinical Trial Identified Number: NCT06580314
Disease:
- Fallopian Tube Endometrioid Adenocarcinoma,
- Fallopian Tube High Grade Serous Adenocarcinoma,
- Ovarian Carcinoma,
- Ovarian High Grade Endometrioid Adenocarcinoma,
- Ovarian High Grade Serous Adenocarcinoma,
- Primary Peritoneal Endometrioid Adenocarcinoma,
- Primary Peritoneal High Grade Serous Adenocarcinoma
Study Phase:
III
researchcancer@cooperhealth.edu
Article Title
A Phase III Trial of One Vs. Two Years of Maintenance Olaparib, with or without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy
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