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POSITIVE

  • Follow up

BOOG 2015-03

General Information

BOOG number

BOOG 2015-03

Nickname

POSITIVE

Status

  • Follow up
Date: 31/12/2019

Inclusion closed

31/12/2019

Participating parties / group

IBCSG, BIG

Other study number

IBCSG 48-14

Full title

Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer

Indication

  • Adjuvant

Subindication

Any HER2, HR+

Description

Safety of interrupting endocrine therapy to permit pregnancy

Target sample size

500

Actual accrual

518 (NL 23)
Date: 01/01/2020

Estimated study completion date

01/01/2020

Contact

Sponsor

International Breast Cancer Study Group (IBCSG)

Principal Investigator(s)

Dr. J.R. Kroep (Leids Universitair Medisch Centrum)

Study manager

Dr. A.E. van Leeuwen-Stok (BOOG SC)

Central datamanagement and randomization

IBCSG Data Management Center IBCSG Registration/Randomization System Randomization Help Desk Phone: +1 716 898 7301 Fax: +1 716 898 7082 Email: bc.helpdesk@fstrf.org

Monitoring

IKNL (monitor@iknl.nl)

Local datamanagement

IKNL (trialbureau@iknl.nl)

Funding

KWF, IBCSG

Other

Informatie voor patiënten over deze studie en de deelnemende ziekenhuizen kunt u vinden op:

https://www.kanker.nl/trials/691-boog-2015-03-positive-studie-borstkanker

Objectives

Primary objective:

To assess the risk of breast cancer relapse associated with temporary interruption of endocrine therapy (ET) to permit pregnancy.

Secondary objective: 

To evaluate factors associated with pregnancy success after interruption ofendocrine therapy.

Endpoints

Primary endpoint:

  • Breast cancer free interval (BCFI) defined as the time from enrollment inthe study to the first invasive BC event (local, regional, or distantrecurrence or a new invasive contralateral BC).

 

Secondary endpoints:

  • Menstruation recovery and pattern.
  • Pregnancy (determined by pregnancy test).
  • Pregnancy outcome: full term pregnancy, caesarean section, abortion,miscarriage, ectopic, stillbirth.
  • Offspring outcome: preterm birth, low birth weight, birth defects.
  • Breastfeeding; pattern of breastfeeding (duration, use ipsilateral breast ifprevious breast conservation, side exclusivity).
  • Use of assisted reproductive technology (ART).
  • Adherence to endocrine treatment assessed by:  Treatment resumption after the ~2 year ET break and total duration of at least 5 years of ET.
  • Distant recurrence-free interval (DRFI), defined as the time fromenrollment in the study to the first BC recurrence in a distant site,excluding second (non-breast) primary cancers and contralateral breastcancer.

Eligibility Criteria

Please refer to the protocol for all inclusion criteria and details

  • Age ≥ 18 and ≤ 42 years at enrollment.
  • Has received adjuvant endocrine therapy (SERM alone, GnRH analogueplus SERM or AI) for ≥18 months but ≤30 months for early breast cancer.
  • The adjuvant endocrine therapy must have stopped within 1 month priorto enrollment.
  • Breast cancer for which patient is receiving endocrine therapy must havebeen histologically-proven stage I-III, endocrine-responsive (i.e., estrogenand/or progesterone receptor positive, according to local definition ofpositive, determined using immunohistochemistry (IHC)), and treatedwith curative intent. Note:
    • Patients with synchronous bilateral invasive breast cancer (diagnosedhistologically within 2 months) are eligible.
    • Patient with invasive breast cancer or synchronous bilateral invasivebreast cancer (diagnosed histologically within 2 months) duringpregnancy are eligible.
    • Patients with BRCA1/2 mutations are eligible.
    • Patients could have received neo/adjuvant chemotherapy, or other systemic therapy (e.g., neo/adjuvant HER2-targeted therapy) accordingto institutional policy and patient’s desire.
  • Written consent to biological material submission, indicating the patienthas been informed of and agrees to tissue and blood material use, transferand handling

Regulatory Information

CCMO approval

Yes
Nr: NL54300.058.15
METC approval:
Yes
METC: Leiden Universitair Medisch Centrum
NUMBER: P15.247/SH/gk
Date: 05/07/2016

Trial Register

NCT023808085

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