Studieoverzicht - 2015-03 POSITIVE

 
Number 2015-03 POSITIVE
Nickname POSITIVE
Status Open Date: 27-07-2016
Inclusion closed
Other study number(s) IBCSG 48-14
Participating parties/groups IBCSG, BIG
Full title Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer
Phase and type Other
Age > 18 and < 40
Menopausal status Premenopausal
Indication Adjuvant
Subindication Any HER2, HR+
Target sample size 500
Actual accrual 348 (NL 14) Date: 31-01-2019
Estimated study completion date 27-07-2020
CCMO approval Date: Nr: NL54300.058.15
EudraCT nr.
Trial Register NCT023808085
METC approval Yes Date: 05-07-2016 METC: Leiden Universitair Medisch Centrum Nr: P15.247/SH/gk
Amendments Date:
KWF-CKS approval Yes Date: 29-06-2015 Nr: UL 2015-7723
News item
Website http://www.ibcsg.org/Public/Health_Professionals/Open_Trials/ibcsg_48-14_positive
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 (monittor@iknl.nl)
Local datamanagement IKNL (trialbureau@iknl.nl)
Funding Logo KWF.jpgKWF
Extra

Design:

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 of endocrine therapy.

Endpoints:

Primary endpoint:

  • Breast cancer free interval (BCFI) defined as the time from enrollment in the study to the first invasive BC event (local, regional, or distant recurrence 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 if previous breast conservation, side exclusivity).
  • Use of assisted reproductive technology (ART).
  • Adherence to endocrine treatment assessed by:

- Treatment resumption after the ~2 year ET break.
- Total duration of at least 5 years of ET.

  • Distant recurrence-free interval (DRFI), defined as the time from enrollment in the study to the first BC recurrence in a distant site, excluding second (non-breast) primary cancers and contralateral breast cancer.
Main 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 analogue plus SERM or AI) for ≥18 months but ≤30 months for early breast cancer.
  • The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment.
  • Breast cancer for which patient is receiving endocrine therapy must have been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen and/or progesterone receptor positive, according to local definition of positive, determined using immunohistochemistry (IHC)), and treated with curative intent.

Note:
- Patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible.
- Patient with invasive breast cancer or synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) during pregnancy 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) according to institutional policy and patient’s desire.

  • Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling
Documents (protected):
In order to see this content you need to be logged on.

Login.

Back