NCT06197581

Brief Summary

Radiation therapy is a crucial part in the comprehensive treatment of breast cancer. In recent years, emerging systemic treatment regimens such as HER 2 inhibitors, CDK 4/6 inhibitors, PARP inhibitors, capecitabine and PD1 inhibitors have greatly improved the prognosis of breast cancer and has become the standard treatment for specific populations. A considerable number of patients require both radiotherapy and maintenance systemic therapy. However, it is not clear whether systemic therapy should be synchronized or suspended in radiotherapy，despite that previous basic research shows that some molecular drug therapy and radiotherapy has a clear synergy mechanism. There is an agent need for a definite evidence to evaluate the safety of synchronous treatment, to support clinical diagnosis and treatment and the next step of comprehensive treatment. The implementation of the new radiotherapy technology represented by IMRT takes into account the prescription dose homogenization and the minimization of normal tissue dosage, which provides a certain basis for the combination therapy. Based on the above conditions, this study intends to enroll patients between 18 and 70 years old with chest wall / breast ± lymphatic drainage area and requiring capecitabine, CDK 4/ 6 inhibitor, HER2 targeted therapy or immunotherapy. Radiation and novel systemic therapies would be delivered concurrently. The study aimed at evaluating the safety of combined treatments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2024Jan 2027

First Submitted

Initial submission to the registry

December 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

January 12, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Expected
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

December 5, 2023

Last Update Submit

August 19, 2024

Conditions

Breast Cancer, Familial MaleRadiotherapy; ComplicationsChemotherapeutic ToxicityImmune Checkpoint InhibitorCDK4/6 InhibitorTrastuzumabPertuzumabPARP Inhibitor

Keywords

Breast CancerRadiotherapyAdverse eventsCapecitabineTrastuzumabPertuzumabImmune checkpoint inhibitorCDK4/6 inhibitorPARP inhibitor

Outcome Measures

Primary Outcomes (1)

  • Grade 3 adverse events

    To investigate the adverse events and safety of the combined treatment.

    Every week during the radiation , week 4 and week 12 after radiation, and at any time when severe symptoms were recorded within 3 months after radiation.

Secondary Outcomes (1)

  • Adverse events with any grade

    Every week during the radiation , week 4 and week 12 after radiation, and at any time when severe symptoms were recorded within 3 months after radiation

Study Arms (5)

RT+capecitabine

OTHER

Patients will receive concurrent radiotherapy and capecitabine.

Radiation: Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)

RT+HER2 inhibitors

OTHER

Patients will receive concurrent radiotherapy and any HER2 inhibitors ( eg. trastuzumab plus pertuzumab or TDM1)

Radiation: Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)

RT+ CDK4/6 inhibitors

OTHER

Patients will receive concurrent radiotherapy and any of the CDK4/6 inhibitors (abemaciclib，palbociclib ,ribociclib or other CDK4/6 inhibitors)

Radiation: Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)

RT+PARP inhibitor.

OTHER

Patients will receive concurrent radiotherapy and PARP inhibitor(Olaparib or other PARP inhibitors)

Radiation: Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)

RT+ICI

OTHER

Patients will receive concurrent radiotherapy and immune checkpoint inhibitor (Pembrolizumab or other anti-PD1/PDL1 regimens).

Radiation: Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)

Interventions

Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)RADIATION

Patients will receive chest wall / breast radiation with or without lymph node region radiation and novel drugs(for specific population according to guidelines) concurrently.

Also known as: capecitabine（For Arm RT+capecitabine）, HER2 inhibitors (For Arm RT+HER2 inhibitors), CDK4/6 inhibitors(For Arm RT+CDK4/6 inhibitors), PARP inhibitors（For Arm RT+PARP inhibitor）, ICIs(For RT+ICI)
RT+ CDK4/6 inhibitorsRT+HER2 inhibitorsRT+ICIRT+PARP inhibitor.RT+capecitabine

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG 0-2. Aged 18-70 years old. Pathologically diagnosed as breast cancer. Need to receive radiotherapy according to guidelines. Radiotherapy target volume included chest wall/breast with or without lymph node regions.
  • Need to receive one of the following therapies according to guidelines, capetabine, CDK4/6 inhibitor, PARP inhibitor , ICIs , HER2 inhibitors.

You may not qualify if:

  • Male breast cancer. Allergy to the upper medicines before. Will receive trastuzumab alone during and/or after radiotherapy. With severe other disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (4)

  • von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5.

    PMID: 28581356RESULT

  • Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmana J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. doi: 10.1056/NEJMoa2105215. Epub 2021 Jun 3.

    PMID: 34081848RESULT

  • Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Tredan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2.

    PMID: 28968163RESULT

  • Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola A, Tanner M, Ahlgren J, Auvinen P, Lahdenpera O, Villman K, Nyandoto P, Nilsson G, Poikonen-Saksela P, Kataja V, Bono P, Junnila J, Lindman H. Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial. J Clin Oncol. 2022 Apr 1;40(10):1051-1058. doi: 10.1200/JCO.21.02054. Epub 2022 Jan 12.

    PMID: 35020465RESULT

MeSH Terms

Conditions

Breast Cancer, Familial MaleBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yirui Zhai, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Bo Lan, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Shulian Wang, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY CHAIR

  • Fei Ma, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY CHAIR

Central Study Contacts

Yirui Zhai, MD

CONTACT

+86-10-87788058januarywind@163.com

Bo Lan, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 5, 2023

First Posted

January 9, 2024

Study Start

January 12, 2024

Primary Completion

January 15, 2026

Study Completion (Estimated)

January 15, 2027

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)