Systemic therapy with or without Up front surgery of the primary tumor in Breast cancer patients with distant Metastases at Initial presenTation (SUBMIT, BOOG 2010-05)

Systemic therapy with or without Up front surgery of the primary tumor in Breast cancer patients with distant Metastases at Initial presenTation (SUBMIT, BOOG 2010-05) - SUBMIT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39378

Enrollment

516

Registered

2011-06-01

Start date

2012-02-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

The aim of this study is to determine the effect of up front surgery of the primary tumor on survival in patients with primary metastatic breast cancer. According to randomization, half of the patie

perform a re-excision or mastectomy (preferred options in UFS group), treat the patient with radiotherapy or accept that a non-radical resection has been performed. This decision is the responsibil

he or she is not bound by restrictions in the protocol. Of note, radiotherapy can be postponed after first-line chemotherapy has been delivered. Concurrent radiotherapy and chemotherapy is not allo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Newly diagnosed primary distant metastatic breast cancer (M1) Anticipated survival of at least 6 months Histological proven breast cancer, hormonal and HER2Neu status should be known T1-T3, resectable T4 status, N0-N3 Performance status of the patient should allow surgery/systemic therapy Age 18 years, or older Informed consent

Exclusion criteria

Exclusion criteria: Primary invasive breast cancer in medical history Other malignancy within the last 10 years, besides basal cell carcinoma of the skin or early stage cervical cancer Surgical treatment / radiotherapy of this breast tumor before randomization Irresectable T4 breast tumor Synchronous bilateral breast cancer

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Overall survival	—

Secondary

Measure	Time frame
Secondary endpoints: Quality of life Two-year survival Number of unplanned local therapies, i.e. surgery or radiotherapy Number of axillary lymph node dissections or axillary radiotherapy Determination of pathological resection margin (margin status) in patients treated by surgery of the primary tumor Type of chemotherapy, immunotherapy and endocrine therapy and number of regimens of systemic therapy during the first 2 years	—

Measure

Time frame

Secondary endpoints: Quality of life Two-year survival Number of unplanned local therapies, i.e. surgery or radiotherapy Number of axillary lymph node dissections or axillary radiotherapy Determination of pathological resection margin (margin status) in patients treated by surgery of the primary tumor Type of chemotherapy, immunotherapy and endocrine therapy and number of regimens of systemic therapy during the first 2 years

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)